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CompletedNCT01585948Updated Mar 26, 2020

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

An observational study in Patients Undergoing Coronary Angiography, sponsored by University of Ioannina. Completed at 1 site in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-03-26.

Sponsored by University of Ioannina · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,104
Ages
18 Years to 90 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Patients Undergoing Coronary Angiography
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 1,104 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University of Ioannina is the lead sponsor of 53 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Any subject eligible for coronary angiography with or without known CV disease for clinical reasons.

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,104 participants (actual)
Biospecimen retention
Samples with dna

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).

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to four years on average.

Secondary outcomes

  1. 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).

    Time frame: Up to 4 years on average.

  2. 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).

    Time frame: Up to 4 years on average.

  3. 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.

    Time frame: Within a maximum period of 4 years.

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01585948
Lead sponsor
University of Ioannina
Collaborators
University Hospital, Ioannina, Catheterization Laboratory of 1st IKA Hospital, Athens
Responsible party
MICHALIS LAMPROS (Professor of Cardiology, Medical School, University of Ioannina, University of Ioannina) — Principal investigator
First posted
Apr 26, 2012
Start date
Nov 2009
Primary completion
May 2013
Completion
Mar 2020
Last update
Mar 26, 2020

Study contacts

Katerina Naka, As Professor
principal investigator · University of Ioannina

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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