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NCT Number: NCT07841847

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

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.

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Key information

Conditions

Cardiac Rehab Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University

Kütahya, 43020, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Ability and willingness to participate in the study and complete the cardiac rehabilitation program

Exclusion criteria

  • Symptoms or signs of myocardial ischemia
  • Significant left ventricular outflow tract obstruction
  • Ventricular arrhythmia
  • Significant valvular heart disease
  • Uncontrolled hypertension
  • Severe comorbid conditions, including end-stage renal disease, advanced liver disease, or chronic inflammatory disease
  • Active malignancy
  • Physical limitations preventing full participation in exercise, including severe musculoskeletal disorders or major orthopedic or neurological comorbidities
  • Body mass index greater than 35 kg/m²
  • History of orthopedic surgery within the previous 6 months
  • Failure to comply with exercise testing or training procedures, or attendance of less than 80% of the rehabilitation program
  • Use of medications known to directly alter miRNA expression, such as certain immunosuppressive agents or chemotherapy drugs
  • Known psychiatric disorder
  • Presence of a permanent cardiac pacemaker

Treatment and study plan

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.

Primary outcomes

  1. Change in miRNA Expression Levels

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

    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.

  2. Change in Inflammatory, Cardiac, and Oxidative Stress Biomarkers

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

    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

  1. Change in Peak Oxygen Uptake (VO₂max)

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

    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.

  2. Change in Maximum Exercise Workload

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

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

  3. Change in Six-Minute Walk Test Distance

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

    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.

  4. Change in Resting Heart Rate

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

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

  5. Change in Maximum Heart Rate

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

    Maximum heart rate achieved during cardiopulmonary exercise testing will be recorded in beats per minute.

  6. Change in Health-Related Quality of Life

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

    Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36) before and after the cardiac rehabilitation program.

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Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Changes in Specific miRNAs and Biochemical Biomarkers Following Personalized Cardiac Rehabilitation in Patients With Coronary Artery Disease

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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