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NCT Number: NCT06867926

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Medicine

Kayseri, 38030, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hasan Kara, M.D.

CONTACT

[email protected]

+905552592665

About this study

Coronary artery disease (CAD) is a significant global health issue and the leading cause of cardiovascular mortality.

Recent research has focused on the impact of oxidative stress, genetic damage, and inflammation in CAD development. Chronic inflammation and oxidative stress can cause cellular damage by increasing the formation of free oxygen radicals. Oxidative stress leads to endothelial dysfunction, inflammation of the vessel wall, and the formation of atherosclerotic plaques. Atherosclerosis is the most common pathological process associated with cardiovascular diseases, and the disease is characterized by a high oxidative stress state, which causes lipid and protein oxidation. Oxidative stress and an imbalance between oxidants and antioxidants can damage important biomolecules such as DNA, lipids, and proteins.

Cardiac rehabilitation (CR) programmes are a recommended therapy with demonstrated efficacy in the treatment of patients with CAD. CR is a holistic approach that combines medical and exercise interventions to improve patients' cardiovascular health and general well-being. Exercise is the foundation of CR. While the literature describes it extensively, there is still some controversy surrounding oxidative stress and exercise. It has been suggested that exercise may increase the production of reactive oxygen molecules associated with oxidative stress, which is a factor in the pathogenesis of CAD. Regular and moderate exercise can have a positive impact on the body by balancing the production of antioxidants, reducing inflammation and oxidative stress. However, it is important to note that exercise should be approached in moderation to avoid any negative effects on the body. Previous studies have focused on risk factors associated with physical fitness, the fibrinolytic system, or lipid profile in cardiac patients. However, there have been relatively few investigations of induced changes in blood.

This study aims to investigate the role of oxidative stress and inflammation in the pathogenesis of CAD and the effects of KR on these pathophysiological processes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Inclusion criteria

for Patient Volunteers

  • 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

Inclusion criteria

for Healthy Volunteers

  • 18 years of age or older
  • Not having a chronic disease (such as uncontrolled diabetes mellitus, hypertension, heart and kidney failure)
  • Not taking regular medication

Exclusion criteria

Exclusion criteria

for Patient Volunteers

  • 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

Exclusion criteria

for Healthy Volunteers

  • 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

Treatment and study plan

Cardiac rehabilitation

Other

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

Primary outcomes

  1. 8-OHdG

    Time frame: 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

    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.

  2. NADPH oxidase (NOX)

    Time frame: 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

    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.

  3. Total antioxidant capacity (TAC)

    Time frame: 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

    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.

  4. Total oxidant status (TOS)

    Time frame: 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

    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.

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

    Time frame: 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hasan KARA, M.D.

CONTACT

[email protected]

+905552592665

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
May 2, 2025

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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