Coronary Chronic Total Occlusion and Oxidative Balance

NCT ID: NCT04754880

Last Updated: 2021-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Progression of Atherosclerotic Plaque Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Comparison of oxidative and antioxidative markers between groups

Intervention Type DIAGNOSTIC_TEST

Oxidant and anti-oxidant markers

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.

Comparison of oxidative and antioxidative markers between groups

Intervention Type DIAGNOSTIC_TEST

Oxidant and anti-oxidant markers

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Comparison of oxidative and antioxidative markers between groups

Oxidant and anti-oxidant markers

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Those who underwent coronary angiography with the diagnosis of stable coronary artery disease
* Elder than 18 years

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ekrem Aksu

Assis. Prof. MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ekrem Aksu

Kahramanmaraş, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15842978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27910082 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8362709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32180036 (View on PubMed)

Increased thiol/disulphide ratio in patients with ST elevation-acute coronary syndromes. Cukurova Medical Journal 2019;44(1):20-25.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 25115763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6823874 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14.10.2020-2020/19/16

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.