Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients

This study has been terminated.

( Positive Predictive value not related to follow up duration. )

First Received on September 13, 2005. Last Updated on October 19, 2010 History of Changes

Sponsor:	Société Française de Cardiologie
Information provided by:	Société Française de Cardiologie
ClinicalTrials.gov Identifier:	NCT00202670

Purpose

The aim of this study is to determine in high risk diabetics if the positive predictive value of stress echocardiography is superior to the positive predictive value of stress scintigraphy in the diagnosis of coronary stenosis > 50%.

Condition	Phase
Diabetes Mellitus	Phase IV

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients :Comparison Between Stress Echocardiography and Stress Scintigraphy in the Detection of Silent Myocardial Ischemia

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Coronary Artery Disease Nuclear Scans

U.S. FDA Resources

Further study details as provided by Société Française de Cardiologie:

Estimated Enrollment:	220
Study Start Date:	January 2004
Study Completion Date:	June 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 SPECT
2 dobutamine echocardiography

Detailed Description:

Comparison Between Stress Echocardiography and Stress Scintigraphy in the Detection of Silent Myocardial Ischemia

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

high risk diabetic patients

Criteria

Inclusion Criteria:

type 2 diabetic patients in women> 60 yo or men > 55 yo, with high risk of coronary artery disease (EF < 40%, ECG abnormalities, renal failure , 2 others risk factors of atherosclerosis)

Exclusion Criteria:

previous documented CAD acute coronary syndrome

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202670

Locations

France
Pitie Salpetriere
Paris, France, 75013
Service de diabétologie - Pitié Salpêtrière
Paris, France, 75013

Sponsors and Collaborators

Société Française de Cardiologie

Investigators

Principal Investigator:

Claude Le Feuvre, MD

AP-HP

More Information

No publications provided by Société Française de Cardiologie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jacqueminet S, Barthelemy O, Rouzet F, Isnard R, Halbron M, Bouzamondo A, Le Guludec D, Grimaldi A, Metzger JP, Le Feuvre C. A randomized study comparing isotope and echocardiography stress testing in the screening of silent myocardial ischaemia in type 2 diabetic patients. Diabetes Metab. 2010 Dec;36(6 Pt 1):463-9. Epub 2010 Sep 15.

Responsible Party:	Société Françaisede Cardiologie
ClinicalTrials.gov Identifier:	NCT00202670 History of Changes
Other Study ID Numbers:	2003-04
Study First Received:	September 13, 2005
Last Updated:	October 19, 2010
Health Authority:	France: Ministry of Health

Keywords provided by Société Française de Cardiologie:

coronary artery disease
stress myocardial scintigraphy
stress echocardiography

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Heart Diseases
Cardiovascular Diseases

Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 12, 2012