Clinical trial NCT01585948: Study of the Effect of Diabetes on the Incidence and the Extent of Coronary Artery Disease
Official title: The Role of Newer and Traditional Risk Factors in the Development, Extent and Manifestation of Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Undergoing Coronary Angiography
Lead sponsor: University of Ioannina
Sponsor class: OTHER
Collaborators: name: University Hospital, Ioannina
name: Catheterization Laboratory of 1st IKA Hospital, Athens
First posted: 2012-04-26
Enrollment: 1104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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.

Primary outcomes:
measure: The incidence and extent of coronary artery disease between diabetics and non-diabetic patients.
timeFrame: Up to four years on average.
Secondary outcomes:
measure: The incidence and extent of coronary artery disease via coronary angiography scores and related biochemical and demographical risk factors.
timeFrame: Up to 4 years on average.
measure: The incidence, extent and clinical manifestation of coronary artery disease and the circulating levels of hs-CRP, adipokines and RAGEs.
timeFrame: Up to 4 years on average.
measure: TCF7L2 gene polymorphims and the incidence and extent of coronary artery disease.
timeFrame: Within a maximum period of 4 years.
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: 2nd Department of Cardiology, University Hospital of Ioannina
Study officials:
affiliation: University of Ioannina
name: Katerina Naka, As Professor
role: PRINCIPAL_INVESTIGATOR
References: