Clinical Trials in Brazil / NCT06579807
Recruiting Not applicable

Cardiac Rehabilitation and Coronary Artery Disease

NCT06579807 · tracked via the Priya Life Science Brazil tracker
Sponsor
Instituto Nacional de Cardiologia de Laranjeiras
Phase
Not applicable
Started
2024-10-01
Last updated
2026-03-27

Condition(s) studied

Coronary Artery DiseaseAtherosclerosis

Investigational drug(s) / intervention(s)

Exercise training

Exercise training: The multimodal supervised exercise program will include aerobic, resistance, and flexibility exercises. The training program will last 12 weeks, performed in 3 weekly sessions lasting 60 minutes each. Aerobic exercise, lasting between 20-30 minutes, will be conducted on a treadmill or stationary bike at an intensity ranging from 75-85% of the maximal heart rate (HR), based on the cardiopulmonary exercise testing. Resistance training, lasting 30 minutes, will include 8 to 10 exercises performed in 3 sets of 10 to 12 maximum repetitions with 1-minute intervals, targeting major muscle groups of the upper and lower limbs, with loads corresponding to 80-90% of the 10-repetitions maximum (RM).

Study summary

Patients with coronary artery disease (CAD) aged 40-70 years will undergo exercise training (thrice weekly for 12 weeks). A reference group composed of healthy individuals will be included. Evaluations will be conducted at baseline and after the intervention period during two visits. During the first visit, carotid artery thickness will be assessed via ultrasound before and after a cardiopulmonary exercise testing. The second visit will include the evaluation of endothelial function using venous occlusion plethysmography. After this, participants will engage in 30 minutes of moderate-intensity aerobic exercise, and blood samples will be collected pre- and post-exercise. Circulating levels of kynurenine pathway (KP) metabolites (Tryptophan, kynurenine, kynurenic acid, and quinolinic acid), pro-inflammatory cytokines, cell adhesion molecules, and lipid profiles will be measured via Enzyme-Linked Immunosorbent Assay (ELISA), multiplex essays, and biochemical analysis; respectively.

Eligibility

Sex
ALL
Min age
40 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Eligible CAD patients will be those aged 40 to 70 years, of both sexes, entering the cardiac rehabilitation program at HUPE. CAD will be defined as any acute coronary syndrome, including myocardial infarction with and without ST-segment elevation, and unstable angina (all defined by characteristic histories, electrocardiographic abnormalities, and cardiac enzyme abnormalities), or obstructive CAD diagnosed via coronary angiography (defined as ≥ 50% stenosis of any epicardial coronary artery) in patients with stable angina. * Healthy controls: adults aged 40 to 70 years, of both sexes, without CAD evidence. Exclusion Criteria: * diagnosis of heart failure, pulmonary disease, Chagas disease, or tuberculosis * regular physical exercise practice (≥ 3 days/week for 30 min) over the past 6 months * malnutrition (body mass index \[BMI\] \< 18.5 kg/m²) * smoking * obesity (BMI ≥ 30 kg/m²)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Rio de Janeiro State University Rio de Janeiro Rio de Janeiro Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06579807 on ClinicalTrials.gov ↗ ← All trials in Brazil