Coronary Artery DiseaseNCT01356836
The Association Between Different Monocyte Subsets and Coronary Collateral Development
An observational study of Coronary Artery Disease and Coronary Ischemia, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
Trial summary
Collateral growth and coronary angiogenesis are chronic adaptations to myocardial ischemia. Collateralization helps to restore blood flow and as a result salvages myocardium in severely ischemic myocardial regions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Ischemia
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to May 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who were found to have >95% stenosis of at least one major coronary artery in their first coronary angiogram were included in this study.
Who may be able to join
- > 95% stenosis of at least one major coronary artery in their first coronary angiogram
Who cannot join
- previous percutaneous or surgical revascularization history
- evidence of ongoing infection and inflammation
- known malignancy and chronic kidney disease (serum creatinine > 1.5 mg/dl
- diabetic patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
1Türkiye Yüksek İhtisas Education and Research Hospital, Department of Cardiology
Ankara, 06550
About this study
Collateral growth and coronary angiogenesis are chronic adaptations to myocardial ischemia. Collateralization helps to restore blood flow and as a result salvages myocardium in severely ischemic myocardial regions. Thus, good collateral development in patients with severe coronary artery disease (CAD) improves ventricular function and prognosis (1-3).
However, coronary collateral development is different among patients even with similar degrees of coronary artery stenosis. Several factors, such as diabetes mellitus (4) and duration of myocardial ischemic symptoms (5) have been reported to effect coronary collateral development. At the cellular level, inflammatory cells, especially monocytes have an important role in collateralization. In a series of experimental studies with animals, it has been shown that monocytes are important elements for development of collateral vessels (6-7). In a recent study, it has been demonstrated that increased circulating monocyte count is related to good collateral development in patients with stable coronary artery disease (8).
Read more
Monocytes in human blood are heterogeneous and can be classified into two subsets according to the presence or absence of the FcγRIII receptor CD16 (9): CD14++CD16- monocytes characterized by high level expression of the CD14 cell surface receptor but no expression of CD16 receptor, and CD14+CD16+ monocytes characterized by the co-expression of CD16 receptor with either high or low level expression of the CD14 receptor. These subsets differ in function and response to several cytokines.
Our aim in this study was to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development.
- Conditions
- Coronary Artery Disease, Coronary Ischemia
- Keywords
- Coronary collateral development, monocyte subsets, collateralization
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Good-poor collateral | Patients who had good and poor collaterals formed 2 groups | |
| Good collateral, Poor collateral | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionMay 2011
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356836
- Sponsor's protocol ID
- Monocyte subsets
- Status last verified
- Mar 2011
- First submitted
- 17 May 2011
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Different Monocyte Subsets and Coronary Collateral Development
- ClinicalTrials.gov ID
- NCT01356836
- Acronym / sponsor ID
- Monocyte subsets
- Conditions
- Coronary Artery Disease, Coronary Ischemia
- Keywords
- Coronary collateral development, monocyte subsets, collateralization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Yuksek Ihtisas HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 20 May 2011 (estimated)
- 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.
Collateral growth and coronary angiogenesis are chronic adaptations to myocardial ischemia. Collateralization helps to restore blood flow and as a result salvages myocardium in severely ischemic myocardial regions. Thus, good collateral development in patients with severe coronary artery disease (CAD) improves ventricular function and prognosis (1-3).
However, coronary collateral development is different among patients even with similar degrees of coronary artery stenosis. Several factors, such as diabetes mellitus (4) and duration of myocardial ischemic symptoms (5) have been reported to effect coronary collateral development. At the cellular level, inflammatory cells, especially monocytes have an important role in collateralization. In a series of experimental studies with animals, it has been shown that monocytes are important elements for development of collateral vessels (6-7). In a recent study, it has been demonstrated that increased circulating monocyte count is related to good collateral development in patients with stable coronary artery disease (8).
Monocytes in human blood are heterogeneous and can be classified into two subsets according to the presence or absence of the FcγRIII receptor CD16 (9): CD14++CD16- monocytes characterized by high level expression of the CD14 cell surface receptor but no expression of CD16 receptor, and CD14+CD16+ monocytes characterized by the co-expression of CD16 receptor with either high or low level expression of the CD14 receptor. These subsets differ in function and response to several cytokines.
Our aim in this study was to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good-poor collateral | – | –Patients who had good and poor collaterals formed 2 groups |
| Good collateral, Poor collateral | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who were found to have >95% stenosis of at least one major coronary artery in their first coronary angiogram were included in this study.
Key inclusion criteria (1 listed)
- > 95% stenosis of at least one major coronary artery in their first coronary angiogram
Key exclusion criteria (4 listed)
- previous percutaneous or surgical revascularization history
- evidence of ongoing infection and inflammation
- known malignancy and chronic kidney disease (serum creatinine > 1.5 mg/dl
- diabetic patients
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
Not reported in the source record.
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 20 May 2011.
Related trials for Coronary Artery Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
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 Coronary Ischemia, run by Yuksek Ihtisas 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 4 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 20 May 2011. 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.
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 20 May 2011.