The Effect of Cardiac Rehabilitation on Ferroptosis in Patients With Coronary Artery Disease | NCT07722637

NCT07722637

Overview

NCT ID: NCT07722637
Lead Sponsor: TC Erciyes UniversityOTHER
Official Title: Evaluation of Ferroptosis-Related Biomarkers in Individuals With Coronary Artery Disease: The Impact of Cardiac Rehabilitation
Brief Summary: 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Jan 1, 2026Actual
Primary Completion Date: Nov 15, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Patients With Coronary Artery Disease (CAD):

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).

Able to undergo cardiopulmonary exercise testing (CPET).

Able to understand the study procedures and provide written informed consent.

Healthy Controls:

Age between 18 and 75 years.

No history of coronary artery disease or other cardiovascular diseases.

No history of chronic systemic diseases, including diabetes mellitus, hypertension, chronic kidney disease, chronic liver disease, inflammatory or autoimmune diseases, or malignancy.

Not receiving regular medication.

Able to provide written informed consent.

Exclusion Criteria:

Patients With Coronary Artery Disease (CAD):

Decompensated heart failure.

Unstable angina pectoris.

Uncontrolled or complex ventricular arrhythmias.

Severe pulmonary hypertension.

Neurological, orthopedic, or musculoskeletal disorders limiting exercise performance.

Absolute contraindications to cardiopulmonary exercise testing or cardiac rehabilitation according to current clinical guidelines.

Chronic kidney failure or chronic liver disease.

Active infection.

Active inflammatory or autoimmune disease.

Active malignancy or history of malignancy.

Pregnancy.

Cognitive or psychiatric disorders that would interfere with study participation or protocol compliance.

Healthy Controls:

History of coronary artery disease or other cardiovascular diseases.

History of chronic systemic diseases, including diabetes mellitus, hypertension, chronic kidney disease, chronic liver disease, inflammatory or autoimmune diseases, or malignancy.

Regular medication use within the previous 6 months.

Active infection.

Pregnancy.

Age younger than 18 years or older than 75 years.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 90Estimated
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Erciyes University Faculty of Medicine

Similar Studies

Participant Group/Arms

Cardiac Rehabilitation GroupExperimental

Patients with coronary artery disease who will participate in a supervised cardiac rehabilitation program in addition to standard medical therapy. Peripheral venous blood samples will be collected before the initiation and after completion of the cardiac rehabilitation program for the assessment of ferroptosis-related gene expression and serum biomarkers.

Behavioral: Cardiac Rehabilitation

CAD Patients Declining Cardiac RehabilitationNo Intervention

Patients with coronary artery disease who voluntarily decline participation in the cardiac rehabilitation program and continue to receive standard medical therapy. A single peripheral venous blood sample will be collected for the assessment of ferroptosis-related gene expression and serum biomarkers.

Healthy Control GroupNo Intervention

Age- and sex-matched healthy volunteers without known cardiovascular or chronic diseases. A single peripheral venous blood sample will be collected for the assessment of ferroptosis-related gene expression and serum biomarkers.