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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Ioannina.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University Hospital, Ioannina
Cetheterization Laboratory of 1st IKA Hospital, Athens
Information provided by (Responsible Party):
MICHALIS LAMPROS, University of Ioannina
ClinicalTrials.gov Identifier:
NCT01585948
First received: August 16, 2011
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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


Condition
Patients Undergoing Coronary Angiography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Role of Newer and Traditional Risk Factors in the Development, Extent and Manifestation of Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by University of Ioannina:

Primary Outcome Measures:
  • The incidence and extent of coronary artery disease between diabetics and non-diabetic patients. [ Time Frame: Up to four years on average. ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Includes retaining blood samples for DNA analyses and biomechemical markers.


Estimated Enrollment: 1000
Study Start Date: November 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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 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). 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.

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585948

Contacts
Contact: Lampros Michalis, Professor 26510 07710 ext 0030 lmihalis@cc.uoi.gr
Contact: Katerina Naka, Lecturer 26510 07710 ext 0030 anaka@cc.uoi.gr

Locations
Greece
Cardiology Department, University Hospital of Ioannina Recruiting
Ioannina, Greece, 45110
Sub-Investigator: Aikaterini Marini, MD         
Sponsors and Collaborators
University of Ioannina
University Hospital, Ioannina
Cetheterization Laboratory of 1st IKA Hospital, Athens
Investigators
Principal Investigator: Katerina Naka, Lecturer University of Ioannina
  More Information

No publications provided

Responsible Party: MICHALIS LAMPROS, Professor of Cardiology, Medical School, University of Ioannina, University of Ioannina
ClinicalTrials.gov Identifier: NCT01585948     History of Changes
Other Study ID Numbers: UOICAD2010
Study First Received: August 16, 2011
Last Updated: April 25, 2012
Health Authority: Scientific Committee of University Hospital of Ioannina: Greece

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014