Coronary Artery DiseaseNCT04070014
Relationship Between Heme Oxygenase 1 Enzyme Level and Coronary SYNTAX Score
An observational study of Coronary Artery Disease and Oxidative Stress, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim of this study is to investigate the relationship between heme oxygenase-1 enzyme level and angiographically determined SYNTAX score in patients with suspected stable coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Oxidative Stress
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 30 Mar 2020
- 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: Consecutive patients from a single center with suspected stable coronary artery disease who are deemed to undergo coronary angiographic evaluation will be included in the study. Patients will be recruited in a non randomized fashion.
Who may be able to join
- Patients with suspected stable coronary artery disease who are deemed to undergo coronary angiographic evaluation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Heme Oxygenase 1 Enzyme Level and SYNTAX Score in Patients With Stable Coronary Artery Disease
Aim of this study is to investigate the relationship between heme oxygenase-1 enzyme level and angiographically determined SYNTAX score in patients with suspected stable coronary artery disease. Consecutive patients who are deemed to undergo coronary angiography due to high pre test probability or evidence of cardiac ischemia in imaging studies will be included in the study. Patients with coronary artery bypass surgery history and severe comorbid illnesses such as active malignancy, chronic obstructive lung disease, stage 3-5 chronic renal failure will be excluded. Serum heme oxygenase levels will be measured by ELISA method and SYNTAX score will be calculated from coronary angiography.
Read the 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.
- Conditions
- Coronary Artery Disease, Oxidative Stress
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between serum heme oxygenase-1 enzyme level and SYNTAX score
Correlation between serum heme oxygenase levels (in pg/ml) and angiographically determined SYNTAX scores (no unit) will be determined statistically.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Oct 2019
- Primary completion25 Nov 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Aytek Simsek, Yeditepe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070014
- Sponsor's protocol ID
- YeditepUH
- Status last verified
- Jun 2020
- First submitted
- 22 Aug 2019
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Heme Oxygenase 1 Enzyme Level and SYNTAX Score in Patients With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04070014
- Acronym / sponsor ID
- YeditepUH
- Conditions
- Coronary Artery Disease, Oxidative Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Yeditepe University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 28 Aug 2019 (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.
Aim of this study is to investigate the relationship between heme oxygenase-1 enzyme level and angiographically determined SYNTAX score in patients with suspected stable coronary artery disease. Consecutive patients who are deemed to undergo coronary angiography due to high pre test probability or evidence of cardiac ischemia in imaging studies will be included in the study. Patients with coronary artery bypass surgery history and severe comorbid illnesses such as active malignancy, chronic obstructive lung disease, stage 3-5 chronic renal failure will be excluded. Serum heme oxygenase levels will be measured by ELISA method and SYNTAX score will be calculated from coronary angiography.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients from a single center with suspected stable coronary artery disease who are deemed to undergo coronary angiographic evaluation will be included in the study. Patients will be recruited in a non randomized fashion.
Key inclusion criteria (1 listed)
- Patients with suspected stable coronary artery disease who are deemed to undergo coronary angiographic evaluation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between serum heme oxygenase-1 enzyme level and SYNTAX score
Time frame: 3 months
Correlation between serum heme oxygenase levels (in pg/ml) and angiographically determined SYNTAX scores (no unit) will be determined statistically.
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 22 Jun 2020.
- 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 Coronary Artery Disease and Oxidative Stress, run by Yeditepe University Hospital 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 1 inclusion and 6 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 22 Jun 2020. 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?
Relationship between serum heme oxygenase-1 enzyme level and SYNTAX score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2020.