Coronary Chronic Total Occlusion and Oxidative Balance

Completed

• Conditions: Progression of Atherosclerotic Plaque; Coronary Artery Disease
• Interventions: Diagnostic Test: Comparison of oxidative and antioxidative markers between groups

• Registration Number: NCT04754880
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief Summary

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.

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Submitted: 2021-01-30
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-12
• Last Update Submitted: 2021-02-12
• Study First Posted: 2021-02-15
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-CTO	Comparison of oxidative and antioxidative markers between groups	This group was defined as no chronic obstruction, except for non-critical stenosis, who underwent coronary angiography with the diagnosis of stable angina pectoris.
CTO	Comparison of oxidative and antioxidative markers between groups	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.

Primary Outcome Measures

Name	Time	Method
Correlation between oxidative balance and chronic total occlusion in stable coronary artery disease	24 months	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.

Trial Locations

Locations (1)

Ekrem Aksu; 🇹🇷 Kahramanmaraş, Turkey