NCT01671306

Brief 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 2 diabetic patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

9 months

First QC Date

August 18, 2012

Last Update Submit

August 22, 2012

Conditions

Coronary Artery Disease

Keywords

Coronary collateralsdiabetes mellitusmonocyte subsets

Study Arms (2)

Collateral, coronary disease

Patients are grouped into 2: Good and poor collateral development

collateral

Patients are grouped into 2: Good and poor collateral development

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Uğur ARSLAN, MD

    Samsun Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of Cardiology

Study Record Dates

First Submitted

August 18, 2012

First Posted

August 23, 2012

Study Start

January 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

August 23, 2012

Record last verified: 2012-08