- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070014
Relationship Between Heme Oxygenase 1 Enzyme Level and Coronary SYNTAX Score
Relationship Between Heme Oxygenase 1 Enzyme Level and SYNTAX Score in Patients With Stable Coronary Artery Disease
Study Overview
Status
Conditions
Detailed Description
Heme oxygenase-1(HO-1) is an enzyme found throughout the body with highest concentrations in tissues of reticuloendothelial system. It degrades heme to biliverdin and produces ferrous iron and carbon monoxide. It is an inducible anti oxidant enzyme production of which increases during high levels of oxidative stress. Synthesis of HO-1 is regulated mainly on transcriptional level.
Coronary artery disease is characterized by high oxidative stress levels. Initiation of atherosclerosis as well as progression and vulnerable plaque formation are shown to be linked to oxidation-anti oxidation imbalance.
Several studies showed a correlation between heme oxygenase-1 level, activity and coronary artery disease. Measuring heme oxygenase-1 activity from peripheral blood samples is technically challenging. Bilirubin levels are used as a marker of heme oxygenase activity and are showed to be related to coronary artery disease. As previously mentioned HO-1 is an inducible enzyme so the increased levels reveal a high oxidative stress situation. High levels of serum HO-1 are found also in other clinical settings such as interstitial pneumonia, malignancies, acute kidney injury.
Burden of coronary artery disease is highly correlated with adverse prognosis in patients with stable coronary artery disease and acute coronary syndrome. SYNTAX score is a well established tool to determine the extent of coronary artery disease. Severity and location of coronary stenoses as well as calcification and morphology are considered in SYNTAX score. Clinical SYNTAX score also incorporates clinical characteristics of patients including age, creatinine clearance, diabetes etc. High SYNTAX score is associated with increased total and cardiovascular mortality.
The aim of this study is to investigate serum heme oxygenase-1 level and SYNTAX score in patients with suspected coronary artery disease. Patients will be recruited from a single center consecutively. Blood samples will be drawn before coronary angiography. SYNTAX score will be calculated for each patient. Demographical and clinical characteristics of patients will also be recorded. Patients without coronary artery disease will be used as control group. Primary outcome measure will be to determine the relationship between HO-1 levels and SYNTAX score.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Yeditepe University Hospital
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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:
- Patients with suspected stable coronary artery disease who are deemed to undergo coronary angiographic evaluation
Exclusion Criteria:
- Patients with history of coronary bypass or other cardiac surgery
- Patients with acute coronary syndrome
- Patients with severe comorbid illnesses including active malignancies, stage 3-5 chronic renal failure, chronic obstructive lung disease
- Patients with clinically overt infectious or inflammatory diseases
- Patients taking medications that possibly interact with heme metabolism
- patients with hemoglobinopathies
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Relationship between serum heme oxygenase-1 enzyme level and SYNTAX score
Time Frame: 3 months
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Correlation between serum heme oxygenase levels (in pg/ml) and angiographically determined SYNTAX scores (no unit) will be determined statistically.
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3 months
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Collaborators and Investigators
Sponsor
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
- YeditepUH
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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