NCT01356836

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
Last Updated

May 20, 2011

Status Verified

March 1, 2011

Enrollment Period

4 months

First QC Date

May 17, 2011

Last Update Submit

May 19, 2011

Conditions

Keywords

Coronary collateral developmentmonocyte subsetscollateralization

Study Arms (2)

Good-poor collateral

Patients who had good and poor collaterals formed 2 groups

Good collateral, Poor collateral

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \> 95% stenosis of at least one major coronary artery in their first coronary angiogram

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1Türkiye Yüksek İhtisas Education and Research Hospital, Department of Cardiology

Ankara, 06550, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 20, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 20, 2011

Record last verified: 2011-03

Locations