ProtecT-2-D trial protocol: cardiovascular protection in patients with type 2 diabetes and established heart and/or vascular disease at a cardio-metabolic clinic-a randomized controlled trial.

BACKGROUND: Cardiovascular disease remains the primary cause of morbidity and mortality despite advancements in the treatment of patients with type 2 diabetes. Effective diabetes management extends beyond blood glucose control and includes cardiovascular prevention and treatment. However, the conventional healthcare model often emphasizes single-disease-specific management, leading to fragmented care. We aim to establish an affordable Cardio-Metabolic Clinic (CMC) that can provide comprehensive assessment and specialized care with a focus on cardiovascular protection. METHODS: The ProtecT-2-D study is a prospective, randomized control trial at the Cardiovascular Research Unit, Odense University Hospital Svendborg, Denmark. In this study, 1500 participants with type 2 diabetes and cardiovascular disease will be randomly assigned in a 2:1 ratio to receive either the intervention: treatment in the CMC, or the control: standard of care. The Cardio-Metabolic Clinic applies a decision-making algorithm coded with the latest guidelines to evaluate lifestyle factors and manage medical treatment. Health examinations are conducted at baseline and after three years, and clinical events will be assessed through registry and journal audits after five and ten years. The primary outcome is the time to the first occurrence of a composite of cardiovascular deaths, non-fatal acute myocardial infarctions, non-fatal stroke, or hospitalization due to heart failure at a time frame of five years. DISCUSSION: The Cardio-Metabolic Clinic represents a pioneering approach to diabetes management that aims to improve patient outcomes by reducing the cardiovascular disease burden. This study could transform diabetes care and offer a multidisciplinary, cost-effective, and specialized treatment. We need to establish the efficacy and feasibility of a CMC to integrate comparable clinics into broader healthcare systems, and potentially enhance cardiovascular health in patients with type 2 diabetes. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06203860.

Electrocardiogram as a screening tool to exclude chronic systolic heart failure with reduced left ventricular ejection fraction.

INTRODUCTION: In recent years, the waiting time for outpatient echocardiography has been increasing. This has potential consequences for patients with de novo systolic heart failure (HF). Thus, screening methods for HF are needed. One method may be electrocardiogram (ECG). We assessed the diagnostic value of the ECG in identifying HF with reduced left ventricle ejection fraction (LVEF) in patients referred from primary care. METHODS: A 2020-2021 observational retrospective study was conducted on patients referred from primary care on suspicion of HF. All patients had ECG performed before LVEF was documented by echocardiography. RESULTS: In total, 248 patients (61.5%) presented with an abnormal ECG. Among these patients, 4.8% had LVEF 41-49% and 7.7% had LVEF ≤ 40%. An abnormal ECG was found to be associated with reduced LVEF. The negative predictive value of the ECG was 99%, regardless of whether the ECG was interpreted by the cardiologist or automatically. Adding the ECG to a logistic model with traditional risk factors, the ECG increased the area under curve from 0.72 to 0.79. CONCLUSION: This study is the first study to assess the value of automatic ECG interpretation compared with a cardiologist's interpretation. The normal ECG can safely exclude HF with LVEF less-than 50% and may serve as a gatekeeping tool to further assist the primary care physician in identifying patients with de novo systolic HF. FUNDING: None. TRIAL REGISTRATION: Not relevant.

Liraglutide treatment is associated with progression of coronary artery fibrous plaque: a prospective 1-year follow-up study in asymptomatic patients with type 2 diabetes.

OBJECTIVE: The objective of this study was to assess the association between clinically indicated liraglutide treatment and coronary artery plaque progression during 1-year follow-up in asymptomatic diabetes. METHODS: Patients were divided into a group receiving liraglutide (Lira+) and a group not receiving liraglutide (Lira-). Coronary computed tomography angiography (CCTA) was performed to assess total atheroma volume (TAV) and subtypes of plaque volumes (dense calcium, fibrous, fibrous-fatty, and necrotic core plaque) and the plaque progression during one year follow-up. RESULTS: Fifty-five patients (27%) receiving liraglutide and 149 (73%) how did not were included. Changes in TAV during 1-year of follow-up were similar in the two groups (38 ± 180 (Lira+) vs. -1 ± 160 mm3 (Lira-), P = 0.13). A greater increase in fibrous plaque volume was seen in the Lira + vs. the Lira- group (34 ± 129 vs. -2 ± 101 mm3, P = 0.04). Changes over 1-year in the other plaque subtypes were similar in the two groups. Treatment duration of liraglutide was not associated with changes in TAV. CONCLUSION: In patients with T2D without known prior coronary artery disease, liraglutide treatment was associated with a significant increase in coronary artery fibrous plaque volume during 1-year follow-up.

Insulin resistance is associated with high-risk coronary artery plaque composition in asymptomatic men between 65 and 75 years and no diabetes: A DANCAVAS cross-sectional sub-study.

BACKGROUND AND AIMS: Insulin resistance (IR) and pre-diabetes are associated with an increased risk of cardiovascular disease (CVD). We aimed to investigate vulnerable plaque composition in relation to IR and pre-diabetes in asymptomatic non-diabetic men. METHODS: All participants underwent a contrast-enhanced coronary computed tomography angiography (CCTA) to evaluate coronary artery plaque burden and plaque composition (necrotic core, dense calcium, fibrotic and fibrous-fatty volume). Homeostasis model assessment of IR (HOMA-IR) was used, and participants were stratified into tertiles. Participants underwent a standard oral glucose tolerance test (OGTT) and were categorized into 2 groups (normal glucose tolerance (NGT) or pre-diabetes). A multivariable linear regression model was used to evaluate the association between vulnerable plaque composition and IR or glycemic group. RESULTS: Four-hundred-and-fifty non-diabetic men without known CAD were included. The mean age was 70 ± 3 years. Participants in the higher HOMA-IR tertile (H-IR) had higher median necrotic plaque volume compared to the lower HOMA-IR tertile (L-IR) (18.2 vs. 11.0 mm3, p = 0.02). H-IR tertile (ß 0.37 [95% CI 0.10-0.65], p = 0.008), pack-years (ß 0.07 [95% CI 0.007-0.14], p = 0.03) and total atheroma volume (TAV) (ß 0.47 [95% CI 0.36-0.57], p < 0.001) remained associated with necrotic plaque volume in the multivariable linear regression model. CONCLUSIONS: IR was associated with necrotic plaque volume in asymptomatic men without diabetes. Thus, even in asymptomatic men without diabetes, IR seems to have an incremental effect on necrotic plaque volume and vulnerable plaque composition.

Is There Any Improvement in Image Quality in Obese Patients When Using a New X-ray Tube and Deep Learning Image Reconstruction in Coronary Computed Tomography Angiography?

Deep learning image reconstruction (DLIR) is a technique that should reduce noise and improve image quality. This study assessed the impact of using both higher tube currents as well as DLIR on the image quality and diagnostic accuracy. The study consisted of 51 symptomatic obese (BMI > 30 kg/m2) patients with low to moderate risk of coronary artery disease (CAD). All patients underwent coronary computed tomography angiography (CCTA) twice, first with the Revolution CT scanner and then with the upgraded Revolution Apex scanner with the ability to increase tube current. Images were reconstructed using ASiR-V 50% and DLIR. The image quality was evaluated by an observer using a Likert score and by ROI measurements in aorta and the myocardium. Image quality was significantly improved with the Revolution Apex scanner and reconstruction with DLIR resulting in an odds ratio of 1.23 (p = 0.017), and noise was reduced by 41%. A total of 88% of the image sets performed with Revolution Apex + DLIR were assessed as good enough for diagnosis compared to 69% of the image sets performed with Revolution Apex/CT + ASiR-V. In obese patients, the combination of higher tube current and DLIR significantly improves the subjective image quality and diagnostic utility and reduces noise.

High-risk coronary artery plaque in asymptomatic patients with type 2 diabetes: clinical risk factors and coronary artery calcium score.

BACKGROUND: High-risk coronary artery plaque (HRP) is associated with increased risk of acute coronary syndrome. We aimed to investigate the prevalence of HRP in asymptomatic patients with type 2 diabetes (T2D), and its relation to patient characteristics including cardiovascular risk factors, diabetes profile, and coronary artery calcium score (CACS). METHODS: Asymptomatic patients with T2D and no previous coronary artery disease (CAD) were studied using coronary computed tomography angiography (CCTA) in this descriptive study. Plaques with two or more high-risk features (HRP) defined by low attenuation, positive remodeling, spotty calcification, and napkin-ring sign were considered HRP. In addition, total atheroma volume (TAV), proportions of dense calcium, fibrous, fibrous-fatty and necrotic core volumes were assessed. The CACS was obtained from non-enhanced images by the Agatston method. Cardiovascular and diabetic profiles were assessed in all patients. RESULTS: In 230 patients CCTA was diagnostic and 161 HRP were detected in 86 patients (37%). Male gender (OR 4.19, 95% CI 1.99-8.87; p < 0.01), tobacco exposure in pack years (OR 1.02, 95% CI 1.00-1.03; p = 0.03), and glycated hemoglobin (HbA1c) (OR 1.04, 95% CI 1.02-1.07; p < 0.01) were independent predictors of HRP. No relationship was found to other risk factors. HRP was not associated with increased CACS, and 13 (23%) patients with zero CACS had at least one HRP. CONCLUSION: A high prevalence of HRP was detected in this population of asymptomatic T2D. The presence of HRP was associated with a particular patient profile, but was not ruled out by the absence of coronary artery calcium. CCTA provides important information on plaque morphology, which may be used to risk stratify this high-risk population. Trial registration This trial was retrospectively registered at clinical trials.gov January 11, 2017 trial identifier NCT03016910.

Diabetic microvascular complications are associated with reduced global longitudinal strain independent of atherosclerotic coronary artery disease in asymptomatic patients with diabetes mellitus: a cross-sectional study.

BACKGROUND: Reduced left ventricular function, assessed by global longitudinal strain (GLS), is sometimes observed in asymptomatic patients with diabetes mellitus (DM) and is often present in patients with diabetes-related microvascular complications. Our aim was to assess the association between microvascular complications, coronary artery plaque burden (PB) and GLS in asymptomatic patients with DM and non-obstructive coronary artery disease (CAD). METHODS: This cross-sectional study included patients with DM without any history, symptoms or objective evidence of obstructive CAD. All patients were identified in the outpatient Clinic of Endocrinology at Odense University Hospital Svendborg. An echocardiography and a coronary computed tomography angiography were performed to assess GLS and the degree of CAD, respectively. A coronary artery stenosis < 50% was considered non-obstructive. A linear regression model was used to evaluate the impact of potential confounders on GLS with adjustment of body mass index (BMI), mean arterial pressure (MAP), microvascular complications, type of diabetes, tissue Doppler average early diastolic mitral annulus velocity (e') and PB. RESULTS: Two hundred and twenty-two patients were included, of whom 172 (77%) had type 2 DM and 50 (23%) had type 1 diabetes. One hundred and eleven (50%) patients had microvascular complications. GLS decreased as the burden of microvascular complications increased (P-trend = 0.01): no microvascular complications, GLS (- 16.4 ± 2.5%), 1 microvascular complication (- 16.0 ± 2.5%) and 2-3 microvascular complications (- 14.9 ± 2.8%). The reduction in GLS remained significant after multivariable adjustment (ß 0.50 [95% CI 0.11-0.88], p = 0.01). BMI (ß 0.12 [95% CI 0.05-0.19]) and MAP (ß 0.05 [95% CI 0.01-0.08]) were associated with reduced GLS. In addition, an increased number of microvascular complications was associated with increased PB (ß 2.97 [95% CI 0.42-5.51], p = 0.02) in a univariable linear regression model, whereas there was no significant association between PB and GLS. CONCLUSIONS: The burden of microvascular complications was associated with reduced GLS independent of other cardiovascular risk factors in asymptomatic patients with DM and non-obstructive CAD. In addition, the burden of microvascular complications was associated with increasing PB, whereas PB was not associated with GLS.