NCT00202670

Brief Summary

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%.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 20, 2010

Status Verified

January 1, 2004

Enrollment Period

6.3 years

First QC Date

September 13, 2005

Last Update Submit

October 19, 2010

Conditions

Diabetes Mellitus

Keywords

coronary artery diseasestress myocardial scintigraphystress echocardiography

Study Arms (2)

1

SPECT

2

dobutamine echocardiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

high risk diabetic patients

You may qualify if:

  • 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)

You may not qualify if:

  • previous documented CAD acute coronary syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pitie Salpetriere

Paris, 75013, France

Location

Service de diabétologie - Pitié Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

  • 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. doi: 10.1016/j.diabet.2010.06.005. Epub 2010 Sep 15.

    PMID: 20832344DERIVED

MeSH Terms

Conditions

Diabetes MellitusCoronary Artery Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Claude Le Feuvre, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2004

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

October 20, 2010

Record last verified: 2004-01

Locations

FR(2)