Diagnosis of Coronary Artery Disease in High Risk Diabeti... | NCT00202670

Studies
Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients

NCT00202670

Sponsor

Société Française de Cardiologie

Status

Terminated

Last Update Posted

Oct 20, 2010Estimated

Enrollment

220Estimated

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2004

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Positive Predictive value not related to follow up duration.

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

May 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2010

Last Update Posted Date

Oct 20, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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%.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		SPECT
2		dobutamine echocardiography

Interventions

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

high risk diabetic patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claude Le Feuvre, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pitie Salpetriere		Paris		75013	France
Service de diabétologie - Pitié Salpêtrière

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20832344	Derived	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.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases