Coronary Arterial Disease (CAD)NCT06867926
The Effect of Cardiac Rehabilitation on Oxidative DNA Damage and Inflammation in Patients With Coronary Artery Disease
A study testing Cardiac rehabilitation in people with Coronary Arterial Disease (CAD), run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- Having heart failure
- Unstable Angina Pectoris
- Complex ventricular arrhythmia
- Having a pacemaker
- Having orthopedic or neurological diseases that prevent exercise
- Having kidney-liver disease
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University Faculty of Medicine
Kayseri, 38030
Hasan Kara, M.D., +905552592665, drhasankara@yandex.com
About this study
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.
Read the detailed description
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.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Cardiac rehabilitation
- Keywords
- Cardiac Rehabilitation, Oxidative DNA damage, Coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationOther
Individuals diagnosed with coronary artery disease will engage in a programme of cardiac rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Study group for cardiac rehabilitation with coronary artery disease | Experimental | Individuals diagnosed with coronary artery disease will engage in a programme of cardiac rehabilitation. Receives: Other: Cardiac rehabilitation |
| Healthy control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start15 May 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Kara, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867926
- Sponsor's protocol ID
- HKara3
- Status last verified
- Apr 2025
- First submitted
- 16 Oct 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cardiac Rehabilitation on Oxidative DNA Damage and Inflammation in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06867926
- Acronym / sponsor ID
- HKara3
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- Cardiac Rehabilitation, Oxidative DNA damage, Coronary artery disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group for cardiac rehabilitation with coronary artery disease | Experimental | Other: Cardiac rehabilitationIndividuals diagnosed with coronary artery disease will engage in a programme of cardiac rehabilitation. |
| Healthy control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 18 years of age or older
- Not having a chronic disease (such as uncontrolled diabetes mellitus, hypertension, heart and kidney failure)
Key exclusion criteria (12 listed)
- Having heart failure
- Unstable Angina Pectoris
- Complex ventricular arrhythmia
- Having a pacemaker
- Having orthopedic or neurological diseases that prevent exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitationIndividuals diagnosed with coronary artery disease will engage in a programme of cardiac rehabilitation. | Other | Study group for cardiac rehabilitation with coronary artery disease |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation in people with Coronary Arterial Disease (CAD), run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hasan KARA, M.D. (+905552592665, drhasankara@yandex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.