The Effect of Cardiac Rehabilitation on Oxidative DNA Damage and Inflammation in Patients With Coronary Artery Disease

NCT06867926 | Recruiting

• 1 other identifier: HKara3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to determine the levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG), an indicator of oxidative stress, and to demonstrate oxidative DNA damage in cardiac rehabilitation treatment in patients with coronary artery disease. Additionally, proinflammatory cytokines TNFα, IL-1β, and IL-6 levels were measured to evaluate the significance of cardiac rehabilitation treatment in patients with coronary artery disease and to assess the correlation between cytokine levels and 8-OHdG levels.

Conditions

Coronary Arterial Disease (CAD)

Keywords

Cardiac Rehabilitation; Oxidative DNA damage; Coronary artery disease

Outcome Measures

Primary Outcomes (5)

• 8-OHdG

  To measure 8-OHdG in serum samples, the investigators will analyze it using the ELISA kit following the kit procedure and measure it on an ELISA reader.

  intervention group, two measurements- before cardiac rehabilitation (one day before the intervention) and two measurements will be taken after cardiac rehabilitation (at the end of the program)A single measurement will be performed on the healthy control

• NADPH oxidase (NOX)

  To measure NOX in serum samples, the investigators will analyze it using the ELISA kit following the kit procedure and measure it on an ELISA reader.

  intervention group, two measurements- before cardiac rehabilitation (one day before the intervention) and two measurements will be taken after cardiac rehabilitation (at the end of the program)A single measurement will be performed on the healthy control

• Total antioxidant capacity (TAC)

  To measure TAC in serum samples, the investigators will analyze it using the ELISA kit following the kit procedure and measure it on an ELISA reader.

  intervention group, two measurements- before cardiac rehabilitation (one day before the intervention) and two measurements will be taken after cardiac rehabilitation (at the end of the program)A single measurement will be performed on the healthy control

• Total oxidant status (TOS)

  To measure TOS in serum samples, the investigators will analyze it using the ELISA kit following the kit procedure and measure it on an ELISA reader.

  intervention group, two measurements- before cardiac rehabilitation (one day before the intervention) and two measurements will be taken after cardiac rehabilitation (at the end of the program)A single measurement will be performed on the healthy control

• Proinflammatory cytokines (TNFα, IL-1β and IL-6)

  To measure TNFα, IL-1β and IL-6 in serum samples, the investigators will analyze it using the ELISA kit following the kit procedure and measure it on an ELISA reader.

  intervention group, two measurements- before cardiac rehabilitation (one day before the intervention) and two measurements will be taken after cardiac rehabilitation (at the end of the program)A single measurement will be performed on the healthy control

Study Arms (2)

Study group for cardiac rehabilitation with coronary artery disease

EXPERIMENTAL

Individuals diagnosed with coronary artery disease will engage in a programme of cardiac rehabilitation.

Other: Cardiac rehabilitation

Healthy control group

NO INTERVENTION

Interventions

Cardiac rehabilitation OTHER

Individuals diagnosed with coronary artery disease will engage in a programme of cardiac rehabilitation.

Study group for cardiac rehabilitation with coronary artery disease

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65 years with a diagnosis of coronary artery disease and no contraindications to cardiac rehabilitation and exercise testing
• Patients who will undergo cardiopulmonary exercise testing before cardiac rehabilitation
• Patients whose cognitive status is sufficient to complete the study and who can cooperate
• years of age or older
• Not having a chronic disease (such as uncontrolled diabetes mellitus, hypertension, heart and kidney failure)
• Not taking regular medication

You may not qualify if:

• Having heart failure
• Unstable Angina Pectoris
• Complex ventricular arrhythmia
• Having a pacemaker
• Having orthopedic or neurological diseases that prevent exercise
• Having kidney-liver disease
• Exercise is contraindicated
• History of inflammatory diseases
• Having a history of cancer-immunologic disease
• Having a history of chronic diseases such as diabetes mellitus, hypertension, heart and kidney failure
• Being on regular medication for the last 6 months
• being under 18 years of age

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Medicine

Kayseri, 38030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Hasan KARA, M.D.

CONTACT

+905552592665; drhasankara@yandex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Assistant Medical Doctor

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: March 10, 2025
• Study Start: May 15, 2025
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)