Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): a non-inferiority randomized controlled trial study protocol.

BACKGROUND: Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life. The level of parasitemia is a known risk factor for congenital transmission. Benznidazole (BZN) is the drug of choice for preconceptional treatment to reduce parasitic load. The fear of treatment-related side effects limits the implementation of the Argentine guideline recommending BZN 60d/300 mg (or equivalent) treatment of T. cruzi seropositive women during the postpartum period to prevent transmission in a future pregnancy. A short and low dose BZN treatment might reduce major side effects and increase compliance, but its efficacy to reduce T. cruzi parasitic load compared to the standard 60d/300 mg course is not yet established. Clinical trials testing alternative BZN courses among women of reproductive age are urgently needed. METHODS AND DESIGN: We are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short low dose 30-day treatment with BZN 150 mg/day (30d/150 mg) vs. BZN 60d/300 mg. We will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at 6 months postpartum, and follow them up with the following specific aims: Specific aim 1: to measure the effect of BZN 30d/150 mg compared to 60d/300 mg preconceptional treatment on parasitic load measured by the frequency of positive Polymerase Chain Reaction (PCR) (primary outcome) and by real-time quantitative PCR (qPCR), immediately and 10 months after treatment. Specific aim 2: to measure the frequency of serious adverse events and/or any adverse event leading to treatment interruption. TRIAL REGISTRATION: ClinicalTrials.gov . Identifier: NCT03672487 . Registered 14 September 2018.

[Effect of collateral circulation on myocardial perfusion using thallium-201]. / Influenza del circolo collaterale sulla perfusione miocardica al tallio-201.

BACKGROUND: The influence of collateral circulation (CC) on thallium-201 myocardial uptake was studied in 69 patients with coronary artery disease who underwent a coronary angiography. MATERIALS AND METHODS: According to Cohen and Rentrop a CC of 2nd and 3rd degree only was considered. A stress-early redistribution 201Tl scintigraphic protocol was utilized. The images were divided into five segments in each projection; the segments with higher uptake were considered as normal (100%). 1035 segments were analyzed and each segment was related to the donor artery on the basis of the 201Tl and angiographic evaluation. Patients were distinguished in single or multi-vessel disease with or without CC. In collateralized segments related to occluded or functionally more severe coronary stenosis, a somewhat significant prevalence of normal thallium-201 perfusion was observed, while in the non collateralized segments a higher prevalence of irreversible thallium defects was observed. CONCLUSIONS: The data suggest that CC is one of the factors responsible for the presence of normal scintigraphic images in patients with severe coronary stenosis or complete occlusion.

Left ventricular filling rate at rest and during exercise in patients with previous myocardial infarction.

The purpose of this investigation was to define, with radionuclide technique, the variation on left ventricular filling rate in patients with coronary artery disease, and to determine the effects of dynamic exercise on this variation. The study was carried out on 91 subjects, 46 patients with anterior and 30 with inferior previous transmural myocardial infarction; 15 healthy subjects were studied as control group. All the patients underwent coronary angiography and left ventriculography. From the left ventricular time activity curve we considered the diastolic parameters of the peak filling rate (PFR). We considered also the relative end-diastolic volume (rEDV) and the relative end-systolic volume (rESV). These parameters were determined at rest and at the fifth minute of a symptom limited dynamic exercise taken in the supine position, on an ergometric bicycle. In normal subjects rest mean PFR values is 3.08 +/- 0.51 edv/s, during exercise occurs a physiological increase and mean PFR values becomes 5.48 +/- 1 edv/s. The patients with previous myocardial infarction show a PFR significantly smaller than in normal subjects. Abnormal PFR indices during exercise are present in a large number of these patients and the higher anomalies of PFR during exercise were found among patients with anterior myocardial infarction. In these patients we found an increase of rESV during exercise. In conclusion myocardial infarction induces significant alterations of the PFR; physical exercise reveals PFR alterations not exhibited at rest and rESV increase during exercise could be responsible for the PFR alteration observed.

Prognostic significance of the evolution of left ventricular ejection fraction in patients with acute myocardial infarction not treated with thrombolytic therapy.

Several controlled trials on the thrombolytic treatment of acute myocardial infarction (AMI) have failed to demonstrate that thrombolysis has a simultaneous positive effect on left ventricular function and survival. One explanation may be that spontaneous changes in left ventricular function occurred during the progression of AMI in control patients. The aim of this study was to evaluate the spontaneous evolution of left ventricular ejection fraction (LVEF) and its prognostic influence on early (1 month) and late (1 year) mortality in patients with AMI. We studied 216 patients admitted to our CCU within 24 h of the onset of symptoms. LVEF was determined by radionuclide ventriculography on admission (RNV1) and at the end of the necrotic phase (RNV2). Fourteen patients died before RNV2. On the basis of LVEF values at RNV1, the remaining 202 patients were divided into two groups: those with a normal LVEF (> or = 55%), and those with an abnormal LVEF (< 55%). Among patients with a normal LVEF at RNV1 (64 patients), a significant increase (> 12%) in LVEF at RNV2 was observed in 12.5%, a significant decrease (> 12%) in 12.5% and no change at all in 75%. All of these patients survived, regardless of the evolution of LVEF. In patients with an abnormal LVEF at RNV1 (138) a significant increase (> 5%) in LVEF at RNV2 was observed in 72.5%, a significant decrease (> 5%) in 6.5% and no change at all in 21%.(ABSTRACT TRUNCATED AT 250 WORDS)

[The development of a computer model in the quantitative assessment of thallium-201 myocardial scintigraphy]. / Sviluppo di un modello informatico nella valutazione quantitativa della scintigrafia miocardica al tallio-201.

Thallium-201 scintigraphy is a widely used noninvasive procedure for the detection and prognostic assessment of patients with suspected or proven coronary artery disease. Thallium uptake can be evaluated by a visual analysis or by a quantitative interpretation. Quantitative scintigraphy enhances disease detection in individual coronary arteries, provides a more precise estimate of the amount of ischemic myocardium, distinguishing scar from hypoperfused tissue. Due to the great deal of data, analysis, interpretation and comparison of thallium uptake can be very complex. We designed a computer-based system for the interpretation of quantitative thallium-201 scintigraphy data uptake. We used a database (DataEase 4.2-DataEase Italia). Our software has the following functions: data storage; calculation; conversion of numerical data into different definitions classifying myocardial perfusion; uptake data comparison; automatic conclusion; comparison of different scintigrams for the same patient. Our software is made up by 4 sections: numeric analysis, descriptive analysis, automatic conclusion, clinical remarks. We introduced in the computer system appropriate information, "logical paths", that use the "IF ... THEN" rules. The software executes these rules in order to analyze the myocardial regions in the 3 phases of scintigraphic analysis (stress, redistribution, re-injection), in the 3 projections (LAO 45 degrees, LAT,ANT), considering our uptake cutoff, obtaining, finally, the automatic conclusions. For these reasons, our computer-based system could be considered a real "expert system".

[Short- and long-term effects of enalapril on the left ventricular function in patients with congestive heart insufficiency]. / Effetti a breve e lungo termine dell'enalapril sulla funzione ventricolare sinistra in pazienti con insufficienza cardiaca congestizia.

Several studies have demonstrated that enalapril causes a clinical and hemodynamic improvement in patients with congestive heart failure. Nevertheless, the drug capability of influencing left ventricular systolic and diastolic indexes has not been evaluated. In 12 patients with severe congestive heart failure (NYHA class III-IV), treated with digitalis and diuretics, we performed a baseline evaluation through a right heart catheterization, echocardiography and radionuclide ventriculography. The effects on left ventricular systolic and diastolic function indexes after the administration of enalapril 5 mg by oral route have been evaluated. After 3 months of chronic therapy with enalapril 5 mg twice daily, we performed a further evaluation through echocardiography and radionuclide ventriculography. At the acute test we observed a significant improvement of left ventricular ejection fraction (EF), left ventricular stroke index (LVSI), and peak of filling rate (PFR), with a significant reduction of pulmonary wedge pressure (PWP) and peripheral vascular resistance (PVR). After 3 months of chronic therapy EF was significantly increased with respect to baseline values (37 +/- 6.9% vs 28.7 +/- 7.9%, p less than 0.05) and showed a further increase after the drug administration (from 37 +/- 6.9% to 48 +/- 5.4%, p less than 0.001). PFR showed a similar behaviour and reached at the follow-up evaluation normal values (from 1.97 +/- 0.7 edv/s to 2.57 +/- 0.6 efv/s, p less than 0.001). Furthermore, the echocardiographic dimensions of the left ventricle decreased significantly with a significant increase of shortening fraction. In conclusion, our study demonstrates that in patients with severe congestive heart failure enalapril improves the left ventricular systolic and diastolic function indexes and this improvement is persistent.

[Training effect and hemodynamic parameters in myocardial infarct patients undergoing rehabilitation]. / Effetto training e parametri emodinamici in pazienti con infarto del miocardio sottoposti a riabilitazione.

Thirty-five patients with previous myocardial infarction underwent a programme of supervised physical rehabilitation. Twenty-two patients achieved a training effect (TE), after rehabilitation, i.e. a decrease of the double product (DP) for corresponding work loads and an increase of their physical work capacity (PWC). Thirteen patients, despite the absence of any clinical signs of decreased performance, did not obtain the above mentioned haemodynamic effects. In all of the patients the ejection fraction (EF) both at rest and during exercise was measured using a nuclear stethoscope. In patients with TE, the EF was 57 +/- 5% at rest, and 64 +/- 9% during exercise; in patients without TE the EF was 52 +/- 8% at rest and 46 +/- 10% during exercise. The correlation between TE (delta% PWC) and EF at rest and during exercise respectively, is positive and statistically significant, but there is a higher (r = 0,73) and more significant (p less than 001) correlation between delta% PWC and EF during exercise.

Short- and long-term results of early rehabilitation after myocardial infarction: physical fitness, hemodynamic assessments and psychological aspects.

4 months of supervised physical training carried out by 70 male postinfarction patients resulted in a 30% statistically significant increase in the total work load achieved, an increased VO2 and O2 pulse, with an equally significant double-product (DP) decrease. Follow-up ergometric tests performed by 35 patients 24 months after rehabilitation exhibited DP comparable to those found at the end of the program. R wave change during exercise ECG, ejection fraction detected by a nuclear probe, echocardiographic assessment of left ventricular performance were compared with training results. The CPI and IPAT tests were used for psychological evaluation. After rehabilitation, the 50% Sten score drop shows that the patients reached almost normal anxiety levels.