Cardiac Rehabilitation and Coronary Artery Disease
NCT Number: NCT06579807
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Disease|Atherosclerosis
Interventions: BEHAVIORAL: Exercise training
Sponsor: Instituto Nacional de Cardiologia de Laranjeiras
Collaborators: Rio de Janeiro State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10
Completion Date: 2026-12-31
Locations: Rio de Janeiro State University, Rio De Janeiro, RJ, 20550-900, Brazil

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.

Primary Outcome Measures: Carotid intima-media thickness, The assessment of the intima-media thickness (IMT) of the left and right common carotid arteries will be performed with the patient in the supine position, with the head turned to the side (45°), using a portable ultrasound device (Logiq-e, GE HealthCare, Boston, MA, USA) with a 9 L linear probe (12 MHz)., Baseline and 12 weeks
Secondary Outcome Measures: Blood biomarkers of kynurenine pathway metabolites, Plasma levels of KP metabolites \[tryptophan (TRP), kynurenine (KYN), quinolinic acid (QUINA), and kynurenic acid (KYNA)\], will be measured using commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kits., Baseline and 12 weeks|Blood biomarkers of inflammation, Pro-inflammatory cytokines \[interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-y)\] will be measured using commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kits., Baseline and 12 weeks|Blood biomarkers of endothelial injury, Plasma levels of soluble P-selectin, vascular cell adhesion molecule-1 (sVCAM-1), and intercellular adhesion molecule-1 (sICAM-1) will be assessed using the Human Cardiovascular Disease Panel 2 magnetic kit (EMD Millipore Corporation, MA, USA), with a sensitivity greater than 0.079 ng/ml., Baseline and 12 weeks|Vascular function, Endothelial-dependent and -independent vascular function will be assessed by venous occlusion plethysmography, Baseline and 12 weeks|Maximal oxygen consumption, Maximal oxygen consumption will be collected breath-by-breath using a silicone mask (Hans Rudolph®, Shawnee, USA) connected to an Ultima CardiO2 metabolic cart (Medical Graphics®, Saint Louis, USA)., Baseline and 12 weeks