The Effect of Cardiac Rehabilitation on Ferroptosis in Patients With Coronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTC Erciyes University
About this trial
Coronary artery disease (CAD) remains a major global health concern and is the leading cause of cardiovascular mortality worldwide. Cardiac rehabilitation (CR) is a comprehensive, evidence-based intervention that integrates exercise training with optimal medical management and has been shown to improve clinical outcomes in patients with CAD. The primary objective of this study is to investigate the effects of cardiac rehabilitation on ferroptosis, an iron-dependent form of regulated cell death, in patients with coronary artery disease.
A total of 90 participants will be enrolled in the study after providing written informed consent. The study population will consist of three groups: 30 patients with CAD who participate in a cardiac rehabilitation program, 30 patients with CAD who voluntarily decline participation in cardiac rehabilitation, and 30 age- and sex-matched healthy volunteers without any known chronic disease. Peripheral venous blood samples will be collected from patients undergoing cardiac rehabilitation both before the initiation of the rehabilitation program and upon its completion. A single blood sample will be obtained from patients who decline participation in cardiac rehabilitation and from healthy control participants.
To evaluate ferroptosis-related molecular alterations, the expression levels of the ferroptosis-associated genes GPX4, SLC7A11, ACSL4, FSP1, NRF2, TFRC, and NCOA4 will be analyzed. In addition, serum concentrations of ferroptosis-related biomarkers, including free iron, 4-hydroxynonenal (4-HNE), malondialdehyde (MDA), and GPX4 protein, will be measured. The molecular and biochemical parameters will be compared among the three study groups, and changes in ferroptosis-related biomarkers before and after the cardiac rehabilitation program will be evaluated in patients undergoing cardiac rehabilitation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 75 years.
Diagnosis of coronary artery disease within the previous 3 months.
Eligible to participate in a cardiac rehabilitation program or voluntarily decline participation in the cardiac rehabilitation program.
Peak exercise capacity of ≥5 metabolic equivalents (METs).
Disqualifiers
Decompensated heart failure.
Unstable angina pectoris.
Uncontrolled or complex ventricular arrhythmias.
Severe pulmonary hypertension.
Trial design
Design model
Parallel
Treatments tested in this trial
Cardiac Rehabilitation
BehavioralA supervised, comprehensive cardiac rehabilitation program consisting of individualized aerobic and resistance exercise training, patient education, lifestyle modification, and cardiovascular risk factor management according to current clinical practice guidelines.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Cardiac Rehabilitation GroupExperimental treatment 1 intervention
Group B: CAD Patients Declining Cardiac RehabilitationNo intervention 0 interventions
Group C: Healthy Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in GPX4 Gene Expression
elative GPX4 gene expression in peripheral blood will be quantified using real-time quantitative polymerase chain reaction (RT-qPCR). Changes in GPX4 gene expression before and after completion of the cardiac rehabilitation program will be evaluated in patients undergoing cardiac rehabilitation. Baseline GPX4 gene expression levels will also be compared among patients undergoing cardiac rehabilitation, patients who decline participation in cardiac rehabilitation, and healthy control participants.
Time frame
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).Secondary outcomes
1
Change in SLC7A11 Gene Expression
Relative SLC7A11 gene expression will be measured using RT-qPCR. Expression levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Time frame
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks)2
Change in ACSL4 Gene Expression
Relative ACSL4 gene expression will be measured using RT-qPCR. Expression levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Time frame
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).3
Change in FSP1 Gene Expression
Relative FSP1 gene expression will be measured using RT-qPCR. Expression levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Time frame
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).4
Change in NRF2 Gene Expression
Relative NRF2 gene expression will be measured using RT-qPCR. Expression levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Time frame
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).Sponsors and contacts
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Source ClinicalTrials.gov