Comparison of the Evaluation of CAD by CT AngioScan and C... | NCT01779986

Studies
Comparison of the Evaluation of CAD by CT AngioScan and Coronary Angiogram

NCT01779986

Sponsor

Université de Sherbrooke

Status

Unknown status

Last Update Posted

Jan 30, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Canada

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 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Feb 2015Estimated

Completion Date

Feb 2015Estimated

First Submitted Date

Jan 28, 2013

First Submission Date that Met QC Criteria

Jan 29, 2013

First Posted Date

Jan 30, 2013Estimated

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

Jan 29, 2013

Last Update Posted Date

Jan 30, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 use of CT Coronary Angioscan (CT-AS) is gaining popularity, but its exact value as evaluation of CAD requires confirmation. We intend to compare the results of CT-AS and convention coronary angiogram results in patients who are scheduled for an ascending aorta aneurysm reparation surgery. These examens are standard of care before this surgery, so there is no additional danger or disadvantage for the patient. We hope to confirm that CT-AS is a reliable screening test for CAD in patient undergoing heart surgery for other reason than CAD.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of CAD	The CAD seen on CT-AS as compared to the results of the gold-standard test of coronary angiogram.	less than 6 monthes between two tests

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ascending aorta aneurysm waiting for surgical correction
Willing to participate
Needing a Coronary angiogram and a CT-AS for medical reasons

Exclusion Criteria:

Refuse to participate
Allergy to contrast material
Incomplete results or having one of the test done in another hospital
Arrythmia
More than 6 months between the two exams

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with ascending aorta aneurysm undergoing preoperative evaluation of CAD by CT-Angioscan and Coronary angiogramm before surgical reparation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerald Gahide, MD PHD	Université de Sherbrooke	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHUS Fleurimont	Recruiting	Sherbrooke	Quebec	J1H 5N4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided