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Comparison of the Evaluation of CAD by CT AngioScan and Coronary Angiogram (CTAS-MCAS)

This study is currently recruiting participants.
Verified January 2013 by Universitaire de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01779986
First received: January 28, 2013
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the Evaluation of CAD by CT AngioScan and Coronary Angiogram in Patient as Part of Preoperative Evaluation in Ascending Aorta Replacement Surgery Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire de Sherbrooke:

Primary Outcome Measures:
  • Presence of CAD [ Time Frame: less than 6 monthes between two tests ] [ Designated as safety issue: No ]
    The CAD seen on CT-AS as compared to the results of the gold-standard test of coronary angiogram.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779986

Locations
Canada, Quebec
CHUS Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Paul Farand, M.Sc     819-346-1110     paul.farand@sherbrooke.ca    
Principal Investigator: Gérald Gahide, MD            
Sub-Investigator: Paul Farand, MD, MSc            
Sub-Investigator: Tamas Z Fulop, MD            
Sub-Investigator: Francis Rivest, MD            
Sponsors and Collaborators
Universitaire de Sherbrooke
Investigators
Principal Investigator: Gerald Gahide, MD PHD Universite de Sherbrooke
  More Information

No publications provided

Responsible Party: Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01779986     History of Changes
Other Study ID Numbers: CTAS-MCAS UdeS 12-073
Study First Received: January 28, 2013
Last Updated: January 29, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013