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

N/ANot Yet RecruitingNCT07841847

Kutahya Health Sciences University46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiac Rehab Coronary Artery Disease

Personalized Cardiac Rehabilitation ProgramBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

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.