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1.
Clin Oral Investig ; 25(6): 3831-3843, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33715064

RESUMO

OBJECTIVES: To evaluate pain, disruptive behavior, and anxiety in children undergoing different local dental anesthetic techniques. METHODS: This randomized/parallel clinical trial analyzed three groups of patients (9-12 years old) (n = 35) who received infiltrative anesthesia using conventional (CA), vibrational (VBA), and computer-controlled techniques (CCLAD). The outcomes were pain self-perception (Wong-Baker Faces Pain Rating Scale (WBF); Numerical Ranting Scale (NRS)), disruptive behavior (Face, Legg, Activity, Crying, Consolability Scale (FLACC)), anxiety (Corah's Dental Anxiety Scale; modified Venham Picture test (VPTm)), and physiological parameters (systolic (SBP)/diastolic pressure (DBP); heart rate (HR); oxygen saturation (SpO2); respiratory rate (RR)). Statistical analysis was accomplished using Kruskall-Wallis test and ANOVA for repeated measures (α = 0.05). RESULTS: Dental anxiety levels at the baseline were similar for all patients. CA promoted less pain than VBA in WBF (p = 0.018) and NRS (p = 0.006) and CCLAD in WBF (p = 0.029). There were no differences in disruptive behavior (FLACC p = 0.573), anxiety (VPTm p = 0.474), blood pressure (SBP p = 0.954; DBP p = 0.899), heart rate (p = 0.726), oxygen saturation (p = 0.477), and respiratory rate (p = 0.930) between anesthetic techniques. CONCLUSION: Conventional technique resulted in less pain perception for dental local anesthesia. CLINICAL RELEVANCE: Conventional technique reduces the self-reported pain in children 9-12 years old, and therefore, the use of additional devices or different anesthetic techniques is not justified.


Assuntos
Anestesia Dentária , Anestesia Local , Anestésicos Locais , Ansiedade , Criança , Ansiedade ao Tratamento Odontológico/prevenção & controle , Humanos , Dor
2.
Acta Odontol Scand ; 78(6): 445-453, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32348168

RESUMO

Objective: To evaluate the influence of different local anaesthetic techniques in pain, disruptive behaviour and anxiety in children´s dental treatment.Material and methods: This was a randomised and parallel clinical trial. The sample consisted of 105 children (5-8 years old) that were divided into three groups (n = 35) according to the anaesthetic technique: conventional anaesthesia (CA); vibrational anaesthesia (VBA); computer-controlled local anaesthesia delivery (CCLAD). The outcomes were self-perception of pain (Wong-Baker Faces Pain Rating Scale - WBF; Numerical Rating Scale - NRS); disruptive behaviour (Face, Legg, Activity, Cry, Consolability Scale - FLACC); anxiety (Corah's Dental Anxiety Scale; modified Venham Picture test - VPTm) and physiological parameters (blood pressure - systolic - SBP and diastolic - DBP; heart rate - HR; oxygen saturation - SpO2; respiratory rate - RR). Data were statistically analysed with Kruskall-Wallis test and ANOVA for repeated measures with Tukey post hoc test (α = 0.05).Results: All the patients exhibited the same level of dental anxiety at baseline (Corah's Dental Anxiety Scale). There was no difference in self-perception pain, irrespective the evaluation tool used (WBF - p = .864; VAS - p = .761). No differences were detected in disruptive behaviour (FLACC - p = .318); anxiety (VPTm - p = .274); blood pressure (SBP - p = .239; DBP - p = .512); heart rate (p = .728); oxygen saturation (p = .348) and respiratory rate (p = .238) between anaesthetic techniques.Conclusion: Different anaesthetic dental local techniques do not affect the levels of pain, disruptive behaviour, anxiety and physiological parameters in children aged 5-8 years old.


Assuntos
Ansiedade ao Tratamento Odontológico , Comportamento Problema , Anestesia Dentária , Anestesia Local , Anestésicos Locais , Criança , Pré-Escolar , Humanos , Dor , Medição da Dor
3.
J Investig Med ; 62(5): 797-803, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24831858

RESUMO

OBJECTIVE: The objective of this study was to provide recommendations for provision of training for sponsor and investigators at Academic Health Centers. BACKGROUND: A subgroup of the Investigational New Drug/Investigational Device Exemption (IND/IDE) Task Force of the Clinical and Translational Science Award (CTSA) program Regulatory Knowledge Key Function Committee was assembled to specifically address how clinical investigators who hold an IND/IDE and thus assume the role of sponsor-investigators are adequately trained to meet the additional regulatory requirements of this role. METHODS: The participants who developed the recommendations were representatives of institutions with IND/IDE support programs. Through an informal survey, the task force determined that a variety and mix of models are used to provide support for IND/IDE holders within CTSA institutions. In addition, a CTSA consortium-wide resources survey was used. The participants worked from the models and survey results to develop consensus recommendations to address institutional support, training content, and implementation. RECOMMENDATIONS: The CTSA IND/IDE Task Force recommendations are as follows: (1) Institutions should assess the scope of Food and Drug Administration-regulated research, perform a needs analysis, and provide resources to implement a suitable training program; (2) The model of training program should be tailored to each institution; (3) The training should specifically address the unique role of sponsor-investigators, and the effectiveness of training should be evaluated regularly by methods that fit the model adopted by the institution; and (4) Institutional leadership should mandate sponsor-investigator training and effectively communicate the necessity and availability of training.


Assuntos
Comitês Consultivos/normas , Aprovação de Equipamentos/normas , Drogas em Investigação/normas , Desenvolvimento de Programas/normas , Pesquisa Translacional Biomédica/educação , Pesquisa Translacional Biomédica/normas , Educação/métodos , Educação/normas , Humanos , Desenvolvimento de Programas/métodos , Pesquisadores/educação , Pesquisadores/normas , Pesquisa Translacional Biomédica/métodos
5.
Acad Med ; 87(3): 279-84, 2012 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-22373618

RESUMO

Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take before the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials.


Assuntos
Centros Médicos Acadêmicos/legislação & jurisprudência , Centros Médicos Acadêmicos/normas , Regulamentação Governamental , Fidelidade a Diretrizes/legislação & jurisprudência , Fidelidade a Diretrizes/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Pesquisa/legislação & jurisprudência , Pesquisa/normas , Pesquisa Translacional Biomédica/normas , United States Food and Drug Administration/legislação & jurisprudência , Animais , Humanos , Ensaio de Proficiência Laboratorial/legislação & jurisprudência , Garantia da Qualidade dos Cuidados de Saúde/legislação & jurisprudência , Padrões de Referência , Pesquisa/organização & administração , Apoio à Pesquisa como Assunto/legislação & jurisprudência , Pesquisa Translacional Biomédica/legislação & jurisprudência , Estados Unidos
6.
Heart ; 98(5): 389-94, 2012 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-22194151

RESUMO

BACKGROUND: Disease progression in heart failure (HF) reflects derangements in neurohormonal systems, and biomarkers of these systems can help to establish the diagnosis and assess the prognosis. Serial measurements of the precursor peptides of the natriuretic and vasopressin systems (midregional proatrial natriuretic peptide (MR-proANP) and C-terminal provasopressin (copeptin), respectively) should add incremental value to risk stratification in ambulatory patients with HF. METHODS AND RESULTS: A cohort of 187 patients with class III-IV HF was prospectively enrolled, with biomarkers collected every 3 months over 2 years and analysed in relation to death/transplantation. Time-dependent analyses (dichotomous and continuous variables) showed that increases in MR-proANP (HR 7.6, 95% CI 1.85 to 31.15, p<0.01) and copeptin (HR 2.7, 95% CI 1.27 to 5.61, p=0.01) were associated with increased risk, but, in multivariate analysis adjusted for troponin T (cTnT) ≥0.01 ng/ml, only raised MR-proANP remained an independent predictor (HR 5.49, 95% CI 1.31 to 23.01, p=0.02). Combined increases in MR-proANP and copeptin (HR 9.01, 95% CI 1.24 to 65.26, p=0.03) with cTnT (HR 11.1, 95% CI 1.52 to 80.85, p=0.02), and increases ≥30% above already raised values identified the patients at greatest risk (MR-proANP: HR 10.1, 95% CI 2.34 to 43.38, p=0.002; copeptin: HR 11.5, 95% CI 2.74 to 48.08, p<0.001). CONCLUSIONS: A strategy of serial monitoring of MR-proANP and, of lesser impact, copeptin, combined with cTnT, may be advantageous in detecting and managing the highest-risk outpatients with HF.


Assuntos
Fator Natriurético Atrial/sangue , Glicopeptídeos/sangue , Insuficiência Cardíaca/sangue , Pacientes Ambulatoriais , Idoso , Biomarcadores/sangue , Progressão da Doença , Feminino , Seguimentos , Insuficiência Cardíaca/epidemiologia , Humanos , Imunoensaio , Masculino , Pessoa de Meia-Idade , Prevalência , Prognóstico , Estudos Prospectivos , Precursores de Proteínas , Curva ROC , Fatores de Risco , Taxa de Sobrevida/tendências , Estados Unidos/epidemiologia
7.
Acad Med ; 86(2): 217-23, 2011 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21169787

RESUMO

PURPOSE: Investigator-initiated research involving investigational drugs and devices is key to improving health. However, this requires the investigator to serve as a "sponsor-investigator," which can be complex and overwhelming. The Investigational New Drug/Investigational Device Exemption (IND/IDE) Taskforce of the Clinical and Translational Science Award (CTSA) consortium carried out a survey to examine how academic health centers (AHCs) assist sponsor-investigators with regulatory responsibilities. METHOD: The 24 CTSA centers existing in 2008 were surveyed regarding regulatory oversight and support for sponsor-investigators. Responses were analyzed by descriptive statistics. The evaluation of survey responses yielded three models of institutional support/oversight. RESULTS: Nineteen centers and one affiliate responded. Eleven (55%) reported having an IND/IDE support office, increased from five (25%) prior to their CTSA award. The volume of investigator-initiated IND/IDE research was highly variable (measured by numbers of investigators, IND/IDE applications, and studies). Oversight, if done, was provided by either the IND/IDE office or elsewhere in the institution. Most IND/IDE offices assisted with IND/IDE submissions and preparation for external audits. Half reported advanced training for sponsor-investigators. Almost all reported a goal to increase IND/IDE research. Important issues include the need for robust training of investigator/staff, appropriate determination of IND-exempt research, and sufficient support for preparing IND/IDE applications. CONCLUSIONS: Investigator-initiated research involving IND/IDEs is essential, but complex. AHCs should examine how they support sponsor-investigators in meeting the complex requirements. A model of either expert consultation/support or full service will minimize risks to participants and institutions, and regulatory noncompliance.


Assuntos
Pesquisa Biomédica , Drogas em Investigação , Equipamentos e Provisões , Centros Médicos Acadêmicos , Distinções e Prêmios , Coleta de Dados , Difusão de Inovações , Humanos , Inquéritos e Questionários , Pesquisa Translacional Biomédica , Estados Unidos
8.
Am J Cardiol ; 106(3): 402-8, 2010 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-20643254

RESUMO

The response to beta blockers in patients with heart failure could be associated with the genotype of drug-metabolizing enzymes and/or drug targets. The purpose of the present study was to determine whether specific genetic polymorphisms in ADRB1 (encoding the beta1-adrenergic receptor), CYP2D6, and UGT1A1 correlated with dose of, or response to, metoprolol or carvedilol treatment in patients with heart failure. A cohort of patients with heart failure (n = 93), characterized as responders or nonresponders to metoprolol (n = 19) or carvedilol (n = 74) therapy, was retrospectively identified. Individual genotyping was performed for a panel of polymorphisms in the ADRB1, CYP2D6, and UGT1A1 genes. Univariate and multivariate analyses were performed to compare the genotype to the metoprolol or carvedilol response status and dose. A nonresponse was identified in 10 of 19 patients taking metoprolol and 32 of 74 patients taking carvedilol. None of the polymorphisms in ADRB1, CYP2D6, and UGT1A1 were associated with a response or nonresponse. However, a significant relation between the carvedilol (but not metoprolol) dose and the ADRB1 and CYP2D6 genotype was observed. Patients homozygous for the ADRB1 389Gly variant or who were CYP2D6 poor metabolizers achieved a significantly higher dose of carvedilol (p = 0.01 and p = 0.02, respectively). In conclusion, polymorphisms in ADRB1, CYP2D6, and UGT1A1 were not associated with a response to metoprolol or carvedilol therapy in our cohort of patients with heart failure. The ADRB1 and CYP2D6 genotype, alone and in haplotype, were significantly associated with the dose of carvedilol.


Assuntos
Antagonistas Adrenérgicos beta/administração & dosagem , Carbazóis/administração & dosagem , Citocromo P-450 CYP2D6/genética , Glucuronosiltransferase/genética , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/genética , Metoprolol/administração & dosagem , Polimorfismo Genético , Propanolaminas/administração & dosagem , Receptores Adrenérgicos beta 1/genética , Idoso , Alelos , Carvedilol , Doença Crônica , Comorbidade , Genótipo , Haplótipos , Insuficiência Cardíaca/terapia , Humanos , Modelos Lineares , Pessoa de Meia-Idade , Fenótipo , Reação em Cadeia da Polimerase , Resultado do Tratamento
9.
J Card Fail ; 15(9): 763-9, 2009 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-19879462

RESUMO

BACKGROUND: Health-related quality of life (HRQOL) is a major clinical outcome for heart failure (HF) patients. We aimed to determine the frequency, durability, and prognostic significance of improved HRQOL after hospitalization for decompensated HF. METHODS AND RESULTS: We analyzed HRQOL, measured serially using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), for 425 patients who survived to discharge in a multicenter randomized clinical trial of pulmonary artery catheter versus clinical assessment to guide therapy for patients with advanced HF. All patients enrolled had 1 or more prior HF hospitalizations or chronic high diuretic doses and 1 or more symptom and 1 sign of fluid overload at admission. Improvement, defined as a decrease of more than 5 points in MLHFQ total score, occurred in 68% of patients by 1 month and stabilized. The degree of 1-month improvement differed (P < .0001 group x time interaction) between 6-month survivors and non-survivors. In a Cox regression model, after adjustment for traditional risk factors for HF morbidity and mortality, improvement in HRQOL by 1 month compared to worsening at 1 month or no change predicted time to subsequent event-free survival (P=.013). CONCLUSIONS: In patients hospitalized with severe HF decompensation, HRQOL is seriously impaired but improves substantially within 1 month for most patients and remains improved for 6 months. Patients for whom HRQOL does not improve by 1 month after hospital admission merit specific attention both to improve HRQOL and to address high risk for poor event-free survival.


Assuntos
Nível de Saúde , Insuficiência Cardíaca/terapia , Hospitalização/tendências , Qualidade de Vida , Adulto , Idoso , Estudos de Coortes , Intervalo Livre de Doença , Feminino , Seguimentos , Insuficiência Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Fatores de Risco , Taxa de Sobrevida/tendências
10.
J Am Coll Cardiol ; 54(18): 1715-21, 2009 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-19850213

RESUMO

OBJECTIVES: The purpose of this study was to determine whether different profiles of cardiac troponin T (cTnT) values assessed over time would yield incremental prognostic information on clinically stable outpatients with heart failure (HF). BACKGROUND: cTnT levels were used to estimate prognosis in HF; however, most studies evaluated hospitalized patients using single measurements. METHODS: A cohort of 172 New York Heart Association functional class III to IV outpatients was prospectively studied with serial cTnT measurements collected every 3 months over a 2-year period. The primary end point was death or cardiac transplantation, and secondary end points included HF hospitalization. RESULTS: Of the 172 patients, 22 (13%) died or underwent transplantation during the first year. Therefore, 150 patients were included in the second-year analysis of 3 pre-determined groups: 1) no serial cTnT elevations (defined as <0.01 ng/ml); 2) 1 or more, but not all cTnT values elevated > or =0.01 ng/ml; and 3) all cTnT values elevated during the first year. During the second year, 30 events occurred: 53 patients had persistently normal cTnT levels (<0.01 ng/ml) with 6 primary events (11%); 57 patients had 1 or more but not all cTnT levels elevated with 11 events (19%); 40 patients demonstrated persistently elevated cTnT levels with 13 (33%) primary events (odds ratio: 3.77; 95% confidence interval: 1.28 to 11.07, p = 0.02). CONCLUSIONS: Elevations in cTnT, even using a low threshold of 0.01 ng/ml, detected during routine clinical follow-up of ambulatory patients with HF, are highly associated with an increased risk of events, particularly with frequent or persistent cTnT elevations of > or =0.01 ng/ml. Therefore, the ability to monitor clinical change through serial cTnT measurements may add to risk assessment in the ambulatory HF population.


Assuntos
Insuficiência Cardíaca/sangue , Pacientes Ambulatoriais , Volume Sistólico/fisiologia , Troponina T/sangue , Função Ventricular Esquerda/fisiologia , Idoso , Ecocardiografia , Feminino , Seguimentos , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Visita a Consultório Médico/tendências , Prognóstico , Estudos Prospectivos
11.
Clin Chim Acta ; 406(1-2): 119-23, 2009 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-19523938

RESUMO

BACKGROUND: ProBNP, the precursor peptide to BNP and NT-proBNP (NP), circulates in patients with chronic heart failure (HF) and appears to be the predominant form of NP. This heterogeneity may confound interpretation of NP concentrations. The aim of this study was to evaluate the response to therapy and prognostic influence of proBNP in a cohort of patients admitted to hospital for decompensated HF. METHODS: We prospectively evaluated 40 Class III-IV patients who received clinically-indicated nesiritide infusions as part of their care. Blood was drawn before, during, and post-infusion, and assayed for proBNP, BNP, and NT-proBNP. RESULTS: All biomarkers were increased at baseline consistent with HF. ProBNP and NT-proBNP demonstrated significant reductions in response to therapy (42% and 18% post-infusion, respectively). In the patients who experienced post-hospital mortality (40% at 6 months), baseline proBNP and BNP concentrations were significantly lower than in survivors. This paradoxical finding may be explained by the end-stage nature of this patient cohort possibly experiencing exhaustion of their NP systems. CONCLUSIONS: Circulating concentrations of proBNP are increased in decompensated HF and similar to NT-proBNP are reduced in response to acute therapy. Paradoxically and similar to BNP, baseline proBNP concentrations were lower in post-hospital non-survivors. While hypothesis generating, the results of this study support a role for proBNP in monitoring therapy and predicting short-term outcome. These findings need to be confirmed in a patient cohort without nesiritide therapy and more moderate HF.


Assuntos
Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/tratamento farmacológico , Peptídeo Natriurético Encefálico/sangue , Peptídeo Natriurético Encefálico/uso terapêutico , Precursores de Proteínas/sangue , Precursores de Proteínas/uso terapêutico , Idoso , Biomarcadores/sangue , Estudos de Coortes , Feminino , Seguimentos , Insuficiência Cardíaca/sangue , Insuficiência Cardíaca/terapia , Humanos , Bombas de Infusão , Cinética , Masculino , Peptídeo Natriurético Encefálico/administração & dosagem , Prognóstico , Precursores de Proteínas/administração & dosagem , Resultado do Tratamento
12.
Clin Chem ; 55(1): 78-84, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19028821

RESUMO

BACKGROUND: Concentrations of B-type natriuretic peptides (BNPs), including N-terminal pro-B-type natriuretic peptide (NT-proBNP), can be used to estimate prognosis in chronic heart failure. Large biologic variability, however, limits the usefulness of serial measurements in individual patients. As a result, the magnitude of change in peptide concentrations that is clinically meaningful remains to be established. METHODS: We studied 172 New York Heart Association class III-IV outpatients. Primary endpoints were death/transplantation or heart failure hospitalization. The magnitude of peptide changes was categorized as no change (<20% increase or decrease from enrollment), > or =20% to < or =80% increase or decrease; and >80% increase or decrease. Changes were also assessed using cutpoints (500 ng/L for BNP and 1000 ng/L for NT-proBNP). RESULTS: Fifty-two patients died or received transplants during the course of the study. Risk reduction for heart failure hospitalization was demonstrated only for BNP decreases of >80% from enrollment [hazard ratio (HR) 0.318, P = 0.0315]. BNP increases from less than to more than the prespecified cutpoint of 500 ng/L were associated with increased mortality risk (HR 2.101, P = 0.0069), whereas decreases from more than to less than the cutpoint did not reduce risk. NT-proBNP decreases from more than to less than the cutpoint of 1000 ng/L were associated with reduced risk of death/transplantation (HR 0.119, P = 0.0354). CONCLUSIONS: BNP increases from less than to more than the cutpoint were associated with increased risk of events, whereas further increases did not add to risk. In contrast, only substantial natriuretic peptide decreases (>80%) reduced risk. These data suggest that only robust decreases in natriuretic peptide concentrations should be targeted to reduce mortality and heart failure-related hospitalizations.


Assuntos
Assistência Ambulatorial , Insuficiência Cardíaca/sangue , Insuficiência Cardíaca/diagnóstico , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Doença Crônica , Estudos de Coortes , Feminino , Seguimentos , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Transplante de Coração , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Radioimunoensaio , Reprodutibilidade dos Testes , Fatores de Risco , Sensibilidade e Especificidade , Índice de Gravidade de Doença , Resultado do Tratamento
13.
J Cardiovasc Transl Res ; 2(4): 526-35, 2009 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-20560012

RESUMO

Multibiomarker paradigms have been proposed to diagnose, define progression, and to monitor therapy of heart failure (HF) patients. The aim of this study was to evaluate the prognostic and therapy-monitoring potential of four novel biomarkers (copeptin, midregional proatrial natriuretic peptide (MR-proANP), neopterin, and procalcitonin) which have been shown to be elevated in the plasma of patients with HF and reported to have prognostic value. In a prospective study of 40 patients hospitalized for decompensated HF and who received nesiritide infusions as part of their care, blood was drawn before, during, and postinfusion and assayed for the novel biomarkers. B-type natriuretic peptide (BNP) and N-terminal pro-BNP (NT-proBNP) which were previously measured and reported in this cohort were also included in the analyses. All biomarkers were elevated at baseline prior to nesiritide infusion, but copeptin, MR-proANP, and NT-proBNP demonstrated significant acute reductions in plasma levels in response to therapy. Copeptin levels were higher in posthospital nonsurvivors and by proportional hazards model were associated with an increased mortality risk (p = 0.04). Procalcitonin and neopterin added no incremental information on response to therapy or risk stratification. In contrast, copeptin and MR-proANP appear to have potential for monitoring acute responses to therapy. Only copeptin and BNP contributed to risk stratification in this cohort of advanced HF patients, but the conjoint use of BNP or NT-proBNP does not appear to impact the prognostic value of copeptin alone. These results are hypothesis generating to stimulate additional investigation.


Assuntos
Fator Natriurético Atrial/sangue , Fármacos Cardiovasculares/administração & dosagem , Monitoramento de Medicamentos , Glicopeptídeos/sangue , Insuficiência Cardíaca/tratamento farmacológico , Peptídeo Natriurético Encefálico/administração & dosagem , Idoso , Biomarcadores/sangue , Calcitonina/sangue , Peptídeo Relacionado com Gene de Calcitonina , Feminino , Insuficiência Cardíaca/sangue , Insuficiência Cardíaca/mortalidade , Humanos , Infusões Intravenosas , Estimativa de Kaplan-Meier , Masculino , Minnesota , Peptídeo Natriurético Encefálico/sangue , Neopterina/sangue , Valor Preditivo dos Testes , Precursores de Proteínas/sangue , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
14.
Clin Chim Acta ; 386(1-2): 20-4, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-17854790

RESUMO

BACKGROUND: NT-proBNP measurements aid in the evaluation of patients with suspected heart failure (HF) and may facilitate risk stratification in patients with HF and acute coronary syndrome (ACS). Point-of-care (POC) assays may provide more timely results and potentially improve patient outcomes. METHODS: We evaluated the analytical performance of the Response Biomedical Corporation whole blood RAMP amino-terminal pro-B type natriuretic peptide (NT-proBNP) POC assay compared to the Roche Elecsys proBNP (NT-proBNP) assay. RESULTS: Intra-day and total imprecision (% CV) ranged from 5.5% to 10.3% at 140, 449 and 1675 ng/L. The lowest concentration that yields a 20% CV was 57 ng/L. The lower limit of detection was 18 ng/L. The upper limit of linearity was validated to 23,428 ng/L with an average recovery of 95%. Correlation by Passing and Bablok regression yielded RAMP=1.01 Elecsys+14.6, r=0.98 (n=540; range of Elecsys values <5 to >35,000). Concordance of RAMP versus Elecsys using cut-offs of 125 ng/L for subjects <75 years and 450 ng/L for subjects > or =75 was 92% (95% CI 89-94%) for a group consisting of 127 apparently healthy individuals and 208 non-healthy subjects without HF, and 99% (95% CI 97-100%) for patients with HF, using the New York Heart Association (NYHA) functional classification. Overall, 80%, 87%, 97% and 100% of the RAMP results and 77%, 85%, 96% and 100% of the Elecsys results were greater than the age appropriate cut-off for NYHA I, II, III or IV groups. For both the RAMP and Elecsys results, the median NT-proBNP value was statistically correlated (increasing) with NYHA I, II, III or IV groups, respectively (p<0.0001), with no significant difference between the two methods. CONCLUSIONS: The POC Response Biomedical RAMP NT-proBNP assay provides comparable results that measured on the FDA cleared Roche Elecsys central laboratory platform.


Assuntos
Bioensaio/métodos , Doença das Coronárias/sangue , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Sistemas Automatizados de Assistência Junto ao Leito , Kit de Reagentes para Diagnóstico , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/análise , Doença das Coronárias/diagnóstico , Feminino , Insuficiência Cardíaca/sangue , Insuficiência Cardíaca/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Valores de Referência , Reprodutibilidade dos Testes , Tamanho da Amostra , Sensibilidade e Especificidade , Fatores de Tempo
15.
Circulation ; 116(3): 249-57, 2007 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-17592074

RESUMO

BACKGROUND: Cardiac troponin T (cTnT) and B-type natriuretic peptide (BNP) have been used to estimate prognosis in heart failure; however, most studies have evaluated decompensated patients with single measurements. To determine if there are advantages to serial measurements, we evaluated stable chronic heart failure patients every 3 months for 2 years. METHODS AND RESULTS: A cohort of 190 New York Heart Association class III-IV heart failure patients was prospectively enrolled from June 2001 to January 2004. Primary end points were death, cardiac transplantation, or hospitalization. At study enrollment cTnT was < 0.01 ng/mL in 87 (45.8%) patients, 0.01 to 0.03 ng/mL in 50 (26.3%) patients, and > 0.03 ng/mL in 53 (27.9%) patients. An increase in cTnT above normal (< 0.01 ng/mL) carried a 3.4-fold increased risk (P=0.019). Further increases (> or = 20%) from an elevated level worsened the overall risk (hazard ratio, 5.09; P<0.001). BNP was elevated (> 95th percentile for age and gender normal population) in 122 (64.2%) patients. An elevation of BNP from normal at any time during the study was associated with a poor outcome, but, once elevated, further changes in BNP (increases or decreases) remained associated with the same risk (hazard ratio, 5.09; P<0.001). Combined elevations of cTnT (> 0.03 ng/mL) and BNP defined the highest risk group (hazard ratio, 8.58; P<0.001). CONCLUSIONS: Elevations of cTnT or BNP from normal detected at any time during clinical follow-up in ambulatory patients with chronic heart failure are highly associated with an increased risk of events. Further increases in cTnT contribute to additional risk. Combined elevations of cTnT and BNP contribute the highest risk. The ability to monitor changes by serial measurements adds substantially to the assessment of risk in this patient population.


Assuntos
Assistência Ambulatorial/métodos , Assistência Ambulatorial/tendências , Insuficiência Cardíaca/sangue , Peptídeo Natriurético Encefálico/sangue , Troponina T/sangue , Idoso , Biomarcadores/sangue , Feminino , Seguimentos , Insuficiência Cardíaca/diagnóstico , Transplante de Coração/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo
16.
Clin Cardiol ; 30(5): 245-50, 2007 May.
Artigo em Inglês | MEDLINE | ID: mdl-17492679

RESUMO

BACKGROUND: Ischemic (ISCM) and idiopathic dilated (IDCM) cardiomyopathies have different responses to therapy and outcomes. Both may demonstrate elevations in troponin and B-type natriuretic peptides, but biomarker levels have not been reported to differ as a function of the etiology of heart failure (HF). Accordingly, we compared these biomarkers in patients with chronic HF. HYPOTHESIS: Biomarker levels of troponin T, troponin I, B-type natriuretic peptide (BNP), and N-terminal prohormone brain natriuretic peptide (NT-proBNP) are quantitatively different between ischemic and idiopathic dilated etiologies of chronic HF. METHODS: Forty patients (27 male, 68 +/- 2 years; LVEF 25 +/- 1%; NYHA Class III-IV) admitted to hospital for acute HF were studied. Biomarkers were drawn at admission prior to treatment intervention. RESULTS: Of the 40 patients, 27 had ISCM and 13 IDCM. Baseline clinical characteristics were similar with the exception of GFR. cTnT, cTnI, and BNP levels were higher in ISCM patients (cTnT: 0.373 +/- 0.145 vs. 0.064 +/- 0.016 ng/mL, p < 0.05; cTnI: 2.02 +/- 0.76 vs. 0.21 +/- 0.11 ng/mL, p < 0.05; BNP: 776 +/- 91 vs. 532 +/- 85 pg/mL, p < 0.05). Cardiovascular mortality during follow up (10 +/- 1 months) was 48% in patients with ISCM and 23% with IDCM (p < 0.05). CONCLUSIONS: Patients with acutely decompensated chronic HF have elevations in troponin and BNP. These elevations, as well as mortality are significantly higher in patients with ISCM compared to IDCM. The differential levels in biomarkers may be due to differences in disease pathogenesis, and fit with the adverse prognosis in these patients.


Assuntos
Insuficiência Cardíaca/sangue , Peptídeo Natriurético Encefálico/sangue , Troponina I/sangue , Troponina T/sangue , Idoso , Biomarcadores/sangue , Cardiomiopatia Dilatada/sangue , Cardiomiopatia Dilatada/complicações , Feminino , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/mortalidade , Humanos , Masculino , Isquemia Miocárdica/sangue , Isquemia Miocárdica/complicações , Fragmentos de Peptídeos/sangue , Prognóstico
17.
J Card Fail ; 13(1): 8-13, 2007 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-17338997

RESUMO

BACKGROUND: The predictive accuracy of physician investigators and nurse coordinators in estimating the risk of rehospitalization and death was determined for 373 hospitalized patients with severe advanced heart failure enrolled in the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness trial. METHODS AND RESULTS: Estimates were made at discharge, and patients were followed for 6 months after hospitalization. A statistical prognostic model was developed from clinical and laboratory data for the end points of rehospitalization and death. Both nurse and physician predictions of death were generally associated with the observed deaths (c-indices of 0.675 and 0.611), although the nurses' prediction was significantly better (chi-square = 4.75, P = .029). The prediction ability of the prognostic model was similar to the physicians' model (c-index = 0.603). The predictions of rehospitalization were much weaker for nurse, physician and prognostic models. CONCLUSIONS: Nurses' estimations of survival in discharged, advanced-stage heart failure patients were superior to either physicians' or model-based predictions. Not nurses, physicians, or the prognostic model provided useful predictions for rehospitalizations, but this may have resulted from the fact that the rehospitalization estimates did not include the death risk.


Assuntos
Insuficiência Cardíaca/epidemiologia , Readmissão do Paciente/estatística & dados numéricos , Adulto , Feminino , Insuficiência Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Cardiovasculares , Enfermeiras e Enfermeiros , Médicos , Prognóstico , Risco , Análise de Sobrevida
18.
Healthc Financ Manage ; 59(12): 36-8, 40, 42, 2005 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-16355753

RESUMO

Strategic planning for cardiovascular services should include formation of a cardiovascular advisory committee composed of key stakeholders. The strategic plan should include an internal assessment, external market analysis, review of operations, development of strategies and initiatives, and a financial analysis. The organization's mission and vision, as well as its financial situation, need to be considered in formulating strategies.


Assuntos
Serviço Hospitalar de Cardiologia/organização & administração , Técnicas de Planejamento , Serviço Hospitalar de Cardiologia/economia , Humanos , Estados Unidos
19.
Am J Cardiol ; 96(6): 837-41, 2005 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-16169373

RESUMO

Elevated plasma natriuretic peptides in heart failure (HF) usually indicate a poor outcome and low levels a compensated state. In advanced chronic HF, however, low levels may reflect an impaired neurohormonal response. To assess this hypothesis, this study analyzed whether N-terminal-pro-B-type natriuretic peptide (NT-pro-BNP) and B-type natriuretic peptide (BNP) levels were related to mortality in 40 patients treated for decompensated chronic HF. Cardiovascular mortality during follow-up (10 +/- 1 months) was 40%. BNP levels were lower in patients who died (487 +/- 60 vs 836 +/- 99 pg/ml, p <0.02), as were NT-pro-BNP levels (9,507 +/- 1,178 vs 17,611 +/- 4,338 pg/ml, p <0.05). These data support the hypothesis that patients with end-stage HF and poor short-term survival have lower natriuretic peptide levels than those who survive. These findings suggest that the natriuretic peptide system can no longer contribute adequately to neurohormonal compensation and that paradoxically low peptide levels are an adverse prognostic marker in advanced HF.


Assuntos
Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/mortalidade , Peptídeo Natriurético Encefálico/sangue , Peptídeo Natriurético Encefálico/uso terapêutico , Idoso , Biomarcadores/sangue , Doença Crônica , Feminino , Seguimentos , Insuficiência Cardíaca/sangue , Humanos , Masculino , Natriuréticos/uso terapêutico , Valor Preditivo dos Testes , Taxa de Sobrevida , Resultado do Tratamento
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