- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04754880
Coronary Chronic Total Occlusion and Oxidative Balance
The Relationship Between Oxidative Stress Markers and Presence of Chronic Total Occlusion in Coronary Artery Disease
The presence of chronic blockage of coronary arteries, which we may accept as the terminal point of atherosclerotic coronary artery disease, is closely associated with a poor prognosis. The Discovery of markers that may distinguish patients with a high risk of chronic total occlusion development among patients monitored with the diagnosis of stable coronary artery disease may be important for being able to reduce the increased mortality and morbidity rates.
Oxidative stress status may be one of the markers that play a role in and/or show the development of chronic total occlusion. It was reported that it has a role in the progression, erosion, and instability of atherosclerotic plaques in coronary arteries. To the best of our knowledge, the relationship between chronic total occlusion development and oxidative stress status in stable coronary artery disease has not been studied.
This study investigated the relationships in the oxidative stress status evaluated over TAS, TOS, OSI, Thiol/Disulfide Homeostasis, and antioxidative vitamin levels and possible differences in patients with noncritical coronary artery disease and those with chronic total occlusion.
Study Overview
Status
Intervention / Treatment
Detailed Description
Chronic total occlusion (CTO) is defined as the complete blockage of the coronary artery characterized by a TIMI 0 flow present for at least 3 months. The presence of chronic blockage of coronary arteries, which we may accept as the terminal point of atherosclerotic coronary artery disease, is closely associated with a poor prognosis. In coronary angiography tests conducted due to stable angina pectoris, it was observed that the incidence of chronic total occlusion varied in the range of 15-30%. Moreover, its actual incidence in society is unknown as it is generally asymptomatic. The Discovery of markers that may distinguish patients with a high risk of chronic total occlusion development among patients monitored with the diagnosis of stable coronary artery disease may be important for being able to reduce the increased mortality and morbidity rates.
Oxidative stress status may be one of the markers that play a role in and/or show the development of chronic total occlusion. Reactive oxygen species which show an increase in the case of oxidative stress emerging by increased production of oxidants on the cellular level or a reduced antioxidant system result in disorders on the tissue and organ levels as a result of the damages they induce on DNA, protein, and lipid structures. It was reported that it has a role in the progression, erosion, and instability of atherosclerotic plaques in coronary arteries. Furthermore, the relationship between oxidative stress and the progression of atherosclerosis in coronary arteries has been usually studied in acute coronary syndrome patients. To the best of our knowledge, the relationship between chronic total occlusion development and oxidative stress status in stable coronary artery disease has not been studied.
This study investigated the relationships in the oxidative stress status evaluated over TAS, TOS, OSI, Thiol/Disulfide Homeostasis, and antioxidative vitamin levels and possible differences in patients with noncritical coronary artery disease and those with chronic total occlusion.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Kahramanmaraş, Turkey, 46050
- Ekrem Aksu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Those who underwent coronary angiography with the diagnosis of stable coronary artery disease
- Elder than 18 years
- Patients who were not have the exclusion criterias
Exclusion Criteria:
- Being under the age of 18,
- Unstable angina pectoris,
- Left ventricular systolic dysfunction (Ejection fraction <50),
- Severe anemia
- pregnancy,
- History of congenital heart disease,
- Thyroid disorders,
- Sepsis,
- Malignancy,
- Chronic hematological disease,
- Malnutrition,
- Collagen tissue disease,
- Obesity (The Body Mass Index >(BMI 30 kg/m2) ,
- moderate to severe liver failure,
- Renal deficiency (Glomerular filtration rate <60 ml/min/1.73m2),
- Severe heart valve disease,
- Slectrolyte disorders,
- Receiving multivitamin and antioxidant supplementation treatment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
non-CTO
This group was defined as no chronic obstruction, except for non-critical stenosis, who underwent coronary angiography with the diagnosis of stable angina pectoris.
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Oxidant and anti-oxidant markers
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CTO
This group was defined as the presence of complete occlusion in one artery and no critical lesions (> 50%) in the other arteries undergoing coronary angiography with the diagnosis of stable angina pectoris.
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Oxidant and anti-oxidant markers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between oxidative balance and chronic total occlusion in stable coronary artery disease
Time Frame: 24 months
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Serum Total thiol (μmol / L), Native thiol (μmol / L), Disulfide (μmol / L), Total oxidant status (TOS) (umol/L), Total antioxidant status (TAS) (mmol/L), Oxidative stress index (TOS/TAS), Vitamin A, ng/ml, Vitamin C (ng/ml), Vitamin C / Vitamin A Ratio will be measured and the correlation of these markers with chronic total occlusion of the coronary artery will be investigated.
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24 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR. Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol. 2005 May 1;95(9):1088-91. doi: 10.1016/j.amjcard.2004.12.065.
- Lesiak M, Cugowska M, Araszkiewicz A, Grygier M, Pyda M, Skorupski W, Mitkowski P, Lanocha M, Grajek S. Impact of the presence of chronically occluded coronary artery on long-term prognosis of patients with acute ST-segment elevation myocardial infarction. Cardiol J. 2017;24(2):117-124. doi: 10.5603/CJ.a2016.0112. Epub 2016 Dec 2.
- Kahn JK. Angiographic suitability for catheter revascularization of total coronary occlusions in patients from a community hospital setting. Am Heart J. 1993 Sep;126(3 Pt 1):561-4. doi: 10.1016/0002-8703(93)90404-w.
- Gulcin I. Antioxidants and antioxidant methods: an updated overview. Arch Toxicol. 2020 Mar;94(3):651-715. doi: 10.1007/s00204-020-02689-3. Epub 2020 Mar 16.
- Increased thiol/disulphide ratio in patients with ST elevation-acute coronary syndromes. Cukurova Medical Journal 2019;44(1):20-25.
- Borekci A, Gur M, Turkoglu C, Selek S, Baykan AO, Seker T, Harbalioglu H, Ozaltun B, Makca I, Aksoy N, Gozukara Y, Cayli M. Oxidative Stress and Spontaneous Reperfusion of Infarct-Related Artery in Patients With ST-Segment Elevation Myocardial Infarction. Clin Appl Thromb Hemost. 2016 Mar;22(2):171-7. doi: 10.1177/1076029614546329. Epub 2014 Aug 12.
- Gensini GG. A more meaningful scoring system for determining the severity of coronary heart disease. Am J Cardiol. 1983 Feb;51(3):606. doi: 10.1016/s0002-9149(83)80105-2. No abstract available.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14.10.2020-2020/19/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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