Progression of Atherosclerotic PlaqueNCT04754880
Coronary Chronic Total Occlusion and Oxidative Balance
An observational study of Progression of Atherosclerotic Plaque and Coronary Artery Disease, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progression of Atherosclerotic Plaque, Coronary Artery Disease
- What is being tested?
- Comparison of oxidative and antioxidative markers between groups
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study consecutively included 29 patients who received coronary angiography with the diagnosis of stable angina pectoris and had a presence of total occlusion in one artery and no critical lesion (>50%) in other arteries in the patient group.
Who may be able to join
- 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
Who cannot join
- Being under the age of 18,
- Unstable angina pectoris,
- Left ventricular systolic dysfunction (Ejection fraction <50),
- Severe anemia
- pregnancy,
- History of congenital heart disease,
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Comparison of oxidative and antioxidative markers between groups
- Keywords
- chronic total occlusion, oxidative balance, stable coronary artery disease, vitamin A, vitamin C, vitamin C/vitamin A ratio.
- 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.
Comparison of oxidative and antioxidative markers between groupsDiagnostic test
Oxidant and anti-oxidant markers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Comparison of oxidative and antioxidative markers between groups | |
| 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. Receives: Diagnostic Test: Comparison of oxidative and antioxidative markers between groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between oxidative balance and chronic total occlusion in stable coronary artery disease
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Progression of Atherosclerotic PlaqueStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekrem Aksu, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754880
- Sponsor's protocol ID
- 14.10.2020-2020/19/16
- Status last verified
- Feb 2021
- First submitted
- 30 Jan 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15842978Lesiak 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.
PubMed 27910082Kahn 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.
PubMed 8362709Gulcin 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.
PubMed 32180036Increased 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.
PubMed 25115763Gensini 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.
PubMed 6823874
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Oxidative Stress Markers and Presence of Chronic Total Occlusion in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04754880
- Acronym / sponsor ID
- 14.10.2020-2020/19/16
- Keywords
- chronic total occlusion, oxidative balance, stable coronary artery disease, vitamin A, vitamin C, vitamin C/vitamin A ratio.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Feb 2021 (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 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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-CTO | – | Diagnostic Test: Comparison of oxidative and antioxidative markers between groupsThis group was defined as no chronic obstruction, except for non-critical stenosis, who underwent coronary angiography with the diagnosis of stable angina pectoris. |
| CTO | – | Diagnostic Test: Comparison of oxidative and antioxidative markers between groupsThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study consecutively included 29 patients who received coronary angiography with the diagnosis of stable angina pectoris and had a presence of total occlusion in one artery and no critical lesion (>50%) in other arteries in the patient group.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- Being under the age of 18,
- Unstable angina pectoris,
- Left ventricular systolic dysfunction (Ejection fraction <50),
- Severe anemia
- pregnancy,
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 |
|---|---|---|
| Comparison of oxidative and antioxidative markers between groupsOxidant and anti-oxidant markers | Diagnostic test | CTO, non-CTO |
Primary outcome
Correlation between oxidative balance and chronic total occlusion in stable coronary artery disease
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Background: PubMed 15842978Christofferson 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.
- Background: PubMed 27910082Lesiak 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.
- Background: PubMed 8362709Kahn 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.
- Background: PubMed 32180036Gulcin 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.
- BackgroundIncreased thiol/disulphide ratio in patients with ST elevation-acute coronary syndromes. Cukurova Medical Journal 2019;44(1):20-25.
- Background: PubMed 25115763Borekci 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.
- Background: PubMed 6823874Gensini 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progression of Atherosclerotic Plaque and Coronary Artery Disease, run by Kahramanmaras Sutcu Imam 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 3 inclusion and 18 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: finished, as of the sponsor's last update on 15 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between oxidative balance and chronic total occlusion in stable coronary artery disease (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754880, which also lists 7 linked publications.
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 15 Feb 2021.