Cardiac Rehabilitation and Coronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorInstituto Nacional de Cardiologia de Laranjeiras
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise training
BehavioralThe 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).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Exercise trainingExperimental treatment 1 intervention
Group B: Control healthyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline and 12 weeksSecondary outcomes
1
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.
Time frame
Baseline and 12 weeks2
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.
Time frame
Baseline and 12 weeks3
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.
Time frame
Baseline and 12 weeks4
Vascular function
Endothelial-dependent and -independent vascular function will be assessed by venous occlusion plethysmography
Time frame
Baseline and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Instituto Nacional de Cardiologia de Laranjeiras
Lead sponsor
Rio de Janeiro State University
Sponsor institution
Rio de Janeiro State University
Collaborator
Source ClinicalTrials.gov