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Completed

NCT Number: NCT01585948

Study of the Effect of Diabetes on the Incidence and the Extent 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.

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Key information

Conditions

Patients Undergoing Coronary Angiography

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Department of Cardiology, University Hospital of Ioannina

Ioannina, 45110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Collaborators

  • Catheterization Laboratory of 1st IKA Hospital, Athens
  • University Hospital, Ioannina

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2020
First posted
Apr 26, 2012
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.