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

Overview

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

Full Title of Study: “The Role of Newer and Traditional Risk Factors in the Development, Extent and Manifestation of Coronary Artery Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 2013

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.

Arms, Groups and Cohorts

  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • The incidence and extent of coronary artery disease between diabetics and non-diabetic patients.
    • Time Frame: 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 Measures

  • The incidence and extent of coronary artery disease via coronary angiography scores and related biochemical and demographical risk factors.
    • Time Frame: 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.
    • Time Frame: 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).
  • TCF7L2 gene polymorphims and the incidence and extent of coronary artery disease.
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Ioannina
  • Collaborator
    • University Hospital, Ioannina
  • Provider of Information About this Clinical Study
    • Principal Investigator: MICHALIS LAMPROS, Professor of Cardiology, Medical School, University of Ioannina – University of Ioannina
  • Overall Official(s)
    • Katerina Naka, As Professor, Principal Investigator, University of Ioannina

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