Effects of Personalized Cardiac Rehabilitation on miRNAs and Biochemical Biomarkers in Patients With Coronary Artery Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorKutahya Health Sciences University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Personalized Cardiac Rehabilitation Program

    Behavioral

    Participants 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

46 Participants
are divided into 1 treatment group
Group A: Personalized Cardiac Rehabilitation GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
2

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.

Time frame
Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program

Secondary outcomes

1

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.

Time frame
Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
2

Change in Maximum Exercise Workload

Maximum exercise workload achieved during cardiopulmonary exercise testing will be recorded in watts.

Time frame
Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
3

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.

Time frame
Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
4

Change in Resting Heart Rate

Resting heart rate will be measured before cardiopulmonary exercise testing and recorded in beats per minute.

Time frame
Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program

Other outcomes

Sponsors and contacts

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