The Scanner in the Coronary Evaluation | NCT00484380

Studies
The Scanner in the Coronary Evaluation

NCT00484380

Sponsor

French Cardiology Society

Status

Completed

Last Update Posted

Mar 16, 2011Estimated

Enrollment

66Actual

Phase

Not Applicable

Conditions

Valvular Disease
Coronary Stenosis

Interventions

Coronary scanner

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

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jun 6, 2007

First Submission Date that Met QC Criteria

Jun 6, 2007

First Posted Date

Jun 8, 2007Estimated

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

Mar 15, 2011

Last Update Posted Date

Mar 16, 2011Estimated

Name	Class
French Federation of Cardiology	OTHER

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

Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with heart valve disease referred for surgery.The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with heart valve disease referred for surgery.

Detailed Description

The diagnostic accuracy of multislice spiral computed tomography coronary angiography in terms of sensitivity, specificity, negative and positive predictive value, the conventional coronary angiography being the gold standard.50 patients scheduled for valve surgery will be screened to conduct an additional multislice spiral computed tomography.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coronary scanner	Procedure	multislice spiral computed tomography coronary angiography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The diagnostic accuracy of coronary scanner (sensitivity, specificity, positive and negative predictive values) in the detection of the coronary stenosis higher than 50%.		a month at the latest after the signature of consent

Secondary Outcomes

Measure	Description	Time Frame
The diagnostic accuracy of coronary scanner to detect the patients requiring or not a coronary revascularisation in more of the valvular surgery.		a month at the latest after the signature of consent

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for valve surgery who need a conventional coronary angiography
Informed Content
Patients affiliated to the social security system

Exclusion Criteria:

Instable condition
Arrhythmia including atrial fibrillation
Impaired renal function
Known contrast allergy
Patients unable to hold an apnea during 20 seconds
Pregnancy
Emergency
People unable to sign the informed content such as major under supervision

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gérard Helft, MD, PHD	Pitié-Salpêtrière Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pitié Salpêtrière Hospital		Paris		75013	France

Condition Browse Module

MeSH Terms

ID	Term
D023921	Coronary Stenosis

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided