Coronary Artery DiseaseNCT01671306
The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus
An observational study of Coronary Artery Disease, run by Samsun Education and Research Hospital.
Trial summary
Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral development in non-diabetic patients with stable coronary artery disease. Our aim in this study is to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development in type… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Oct 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of 83 consecutive type 2 diabetic patients who have undergone coronary angiography because of stable symptoms and signs of coronary artery disease. The main inclusion criterion was the presence of >95% stenosis of at least one major coronary artery in their first coronary angiogram.
Who may be able to join
- presence of > 95% stenosis of at least one major coronary artery in their first coronary angiogram.
Who cannot join
- Patients experiencing acute coronary syndrome either with or without ST elevation in the last one month
- Evidence of ongoing infection and inflammation, known malignancy and chronic kidney disease
About this study
Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral development in non-diabetic patients with stable coronary artery disease. Our aim in this study is to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development in type 2 diabetic patients.
Read the detailed description
83 diabetic patients with severe coronary artery disease were enrolled in the study. These patients were investigated according to their collateral development. Monocytes and their subtypes, namely CD14++CD16- and CD14+CD16+ cells were compared in 2 groups
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary collaterals, diabetes mellitus, monocyte subsets
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
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 |
|---|---|---|
| Collateral, coronary disease | Patients are grouped into 2: Good and poor collateral development | |
| collateral | Patients are grouped into 2: Good and poor collateral development |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionOct 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ugur ARSLAN, Samsun Education and Research Hospital
- Investigators
- Uğur ARSLAN, MD, Principal investigator, Samsun Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671306
- Sponsor's protocol ID
- 1037
- Other IDs
- Samsun EAH
- Status last verified
- Aug 2012
- First submitted
- 18 Aug 2012
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01671306
- Acronym / sponsor ID
- 1037
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary collaterals, diabetes mellitus, monocyte subsets
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Aug 2012 (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.
Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral development in non-diabetic patients with stable coronary artery disease. Our aim in this study is to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development in type 2 diabetic patients.
Detailed description
83 diabetic patients with severe coronary artery disease were enrolled in the study. These patients were investigated according to their collateral development. Monocytes and their subtypes, namely CD14++CD16- and CD14+CD16+ cells were compared in 2 groups
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collateral, coronary disease | – | –Patients are grouped into 2: Good and poor collateral development |
| collateral | – | –Patients are grouped into 2: Good and poor collateral development |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of 83 consecutive type 2 diabetic patients who have undergone coronary angiography because of stable symptoms and signs of coronary artery disease. The main inclusion criterion was the presence of >95% stenosis of at least one major coronary artery in their first coronary angiogram.
Key inclusion criteria (1 listed)
- presence of > 95% stenosis of at least one major coronary artery in their first coronary angiogram.
Key exclusion criteria (2 listed)
- Patients experiencing acute coronary syndrome either with or without ST elevation in the last one month
- Evidence of ongoing infection and inflammation, known malignancy and chronic kidney disease
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 23 Aug 2012.
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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.
Uğur ARSLAN, MD principal investigator
Samsun Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Samsun Education and Research Hospital.
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 2 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 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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 23 Aug 2012.