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

The Role of Newer and Traditional Risk Factors in the Development, Extent and Manifestation of Coronary Artery Disease

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

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Coronary Angiography

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 Type: Observational
• Enrollment (Actual): 1104

Contacts and Locations

Study Locations

• Greece
  • Ioannina, Greece, 45110
    • 2nd Department of Cardiology, University Hospital of Ioannina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Diabetics and non-diabetics who are admitted in the Cardiology Department in the University Hospital of Ioannina and undergo coronary angiography for clinical purposes will be studied. The study will include subjects who have suspected stable CAD or an acute coronary syndrome and undergo a diagnostic angiography. Patients revascularized in the past (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.

We plan to recruit about 1,000 patients in about 2 years in order for valid conclusions to be drawn from association analysis between CV risk factors, gene polymorphisms and the presence and extent of CAD.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Diabetes Mellitus; All patients undergoing coronary angiography who are diabetics.
No diabetes mellitus; All patients undergoing coronary angiography that are non-diabetics.
Coronary angiography patients; Diabetics and non-diabetics with or without known CV disease who are admitted in the Department of Cardiology in the University Hospital of Ioannina and the Catheterization Laboratory of 1st IKA Hospital in Athens and undergo coronary angiography for clinical purposes will be studied. The study will include subjects who 1) have suspected CAD and undergo a scheduled diagnostic angiogram for clinical reasons, and 2) are hospitalized because of an acute coronary syndrome and thus undergo diagnostic angiography (with or without previous history of CAD).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence and extent of coronary artery disease via coronary angiography scores and related biochemical and demographical risk factors.	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).	Up to 4 years on average.
The incidence, extent and clinical manifestation of coronary artery disease and the circulating levels of hs-CRP, adipokines and RAGEs.	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).	Up to 4 years on average.
TCF7L2 gene polymorphims and the incidence and extent of coronary artery disease.	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.	Within a maximum period of 4 years.

Collaborators and Investigators

• Sponsor: University of Ioannina
• Collaborators: University Hospital, Ioannina; Catheterization Laboratory of 1st IKA Hospital, Athens
• Investigators: Principal Investigator: Katerina Naka, As Professor, University of Ioannina

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: August 16, 2011
• First Submitted That Met QC Criteria: April 25, 2012
• First Posted (Estimate): April 26, 2012

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: UOICAD2010