Study of the Effect of Diabetes on the Incidence and the Extent of Coronary Artery Disease

Completed

• Conditions: Patients Undergoing Coronary Angiography

• Registration Number: NCT01585948
• Lead Sponsor: University of Ioannina

Brief Summary

In the present study the investigators will measure the extent of coronary artery disease via coronary angiography and the correlating risk factors.

Detailed Description

In the present study the investigators will examine the risk factors determining the development, extent and the manifestation of coronary artery disease. The study will recruit patients undergoing coronary angiography for clinical purposes.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-26
• Primary Completion: 2013-05
• Status Verified: 2020-03
• Study Completion: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1104

Inclusion Criteria

• Any subject eligible for coronary angiography with or without known CV disease for clinical reasons.

Exclusion Criteria

• Patients revascularized in the past, with either coronary artery bypass grafting or percutaneous coronary intervention, will be excluded from the study since it is not possible to describe the extent of CAD in these patients.
• Moderate or severe aortic stenosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence and extent of coronary artery disease between diabetics and non-diabetic patients.	Up to four years on average.	We will investigate the incidence, extent and clinical manifestation of coronary artery disease in diabetics and non-diabetics undergoing coronary angiography for clinical reasons.

Secondary Outcome Measures

Name	Time	Method
TCF7L2 gene polymorphims and the incidence and extent of coronary artery disease.	Within a maximum period of 4 years.	To associate the incidence, extent and clinical manifestation of coronary artery disease with the rs7903146 single nucleotide polymorphism of TCF7L2 gene, that has been strongly associated with diabetes mellitus development.
The incidence and extent of coronary artery disease via coronary angiography scores and related biochemical and demographical risk factors.	Up to 4 years on average.	To associate the incidence, extent and clinical manifestation of coronary artery disease with classic demographic risk factors (such as smoking, alcohol consumption, physical exercise, arterial hypertension, family history of diabetes mellitus or coronary artery disease) and common biochemical risk factors (such as fasting glucose levels, urea, creatinine, HbA1c%, uric acid, total cholesterol, HDL, LDL, triglycerides, VLDL, glomerular filtration rate - GFR).
The incidence, extent and clinical manifestation of coronary artery disease and the circulating levels of hs-CRP, adipokines and RAGEs.	Up to 4 years on average.	To associate the incidence, extent and clinical manifestation of coronary artery disease with systemic inflammatory status assessed by hs-CRP levels, circulating adipokines (adiponectin, resistin) and the receptors of advanced glycation end products (sRAGE and esRAGE).

Trial Locations

Locations (1)

2nd Department of Cardiology, University Hospital of Ioannina; 🇬🇷 Ioannina, Greece