About this trial
This prospective interventional study aims to investigate changes in specific microRNAs (miRNAs) and biochemical biomarkers following a personalized cardiac rehabilitation program in patients with coronary artery disease. A total of 46 participants aged 35-75 years who have undergone percutaneous coronary intervention or coronary artery bypass graft surgery and are eligible for cardiac rehabilitation will be included. Participants will complete a structured, individualized cardiac rehabilitation program lasting 6-8 weeks. Clinical assessments, cardiopulmonary exercise testing, and blood-based biomarker measurements will be performed before and after the rehabilitation program. The primary objective is to determine changes in miRNA and biochemical biomarker levels after cardiac rehabilitation and to evaluate the relationship between these changes and clinical improvement. The findings may contribute to a better understanding of biological responses to cardiac rehabilitation and support the development of more personalized rehabilitation strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Stable coronary artery disease
History of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
Referred and considered clinically eligible for a structured cardiac rehabilitation program
Achievement of a respiratory quotient (RQ) of at least 1.0 during the baseline cardiopulmonary exercise test
Disqualifiers
Symptoms or signs of myocardial ischemia
Significant left ventricular outflow tract obstruction
Ventricular arrhythmia
Significant valvular heart disease
Trial design
Single group
Treatments tested in this trial
Personalized Cardiac Rehabilitation Program
BehavioralParticipants will receive a structured, individualized cardiac rehabilitation program consisting of 30 supervised aerobic exercise sessions performed on a cycle ergometer. Each session will last approximately 45-60 minutes and will include a 5-10-minute low-intensity warm-up, an individualized aerobic exercise phase, and a gradual cool-down period. Exercise intensity will be prescribed according to baseline cardiopulmonary exercise testing and maximal exercise capacity. Training intensity will begin at approximately 40-50% of VO₂max, progress to 60-70% of VO₂max corresponding to a Borg Rating of Perceived Exertion of approximately 12-15, and may reach approximately 80% of VO₂max when clinically appropriate and well tolerated. Exercise workload will be individualized based on the maximal workload achieved during baseline cardiopulmonary exercise testing.
Treatment groups
Trial outcomes
Primary outcomes
Change in miRNA Expression Levels
Changes in the expression levels of miR-21, miR-126, miR-92a, miR-1, miR-155, and miR-133a will be assessed using quantitative real-time polymerase chain reaction (qRT-PCR) before and after completion of the cardiac rehabilitation program.
Change in Inflammatory, Cardiac, and Oxidative Stress Biomarkers
Changes in circulating levels of NT-proBNP, troponins, hs-CRP, IL-6, TNF-α, ST2, semaphorins, MDA, ADMA, and eNOS will be assessed before and after the cardiac rehabilitation program.
Secondary outcomes
Change in Peak Oxygen Uptake (VO₂max)
Peak oxygen uptake will be assessed using cardiopulmonary exercise testing (CPET) performed on a cycle ergometer. VO₂max will be recorded in mL/kg/min as an indicator of maximal aerobic exercise capacity.
Change in Maximum Exercise Workload
Maximum exercise workload achieved during cardiopulmonary exercise testing will be recorded in watts.
Change in Six-Minute Walk Test Distance
Functional exercise capacity will be assessed using the Six-Minute Walk Test. Participants will be instructed to walk as far as possible without running along a 30-meter corridor for six minutes. The total distance walked will be recorded in meters.
Change in Resting Heart Rate
Resting heart rate will be measured before cardiopulmonary exercise testing and recorded in beats per minute.
Sponsors and contacts
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