Study of the Effect of Diabetes on the Incidence and the Extent of Coronary Artery Disease
This study is currently recruiting participants.
Verified April 2012 by University of Ioannina
Sponsor:
University of Ioannina
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 19, 2013