Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)
November 24, 2010 updated by: St. Joseph's Healthcare Hamilton
The Ontario Multidetector Computed Tomography (MDCT) Coronary Angiography Study (OMCAS)
Multidetector Computed Tomographic Coronary Angiography (MDCTCA) has been recently demonstrated to be accurate and may be used as a potential alternative to conventional invasive coronary angiography, which requires cardiac catheterization, for the diagnosis of coronary artery disease.
The purpose of this study is to see if MDCTCA can identify significant coronary artery disease as good as or better than conventional coronary angiography (CICA).
The study is designed to enroll 900 subjects and is being conducted in 6 hospitals in Ontario.
Subjects scheduled for conventional cardiac catheterization and coronary angiography will receive an additional test using MDCTCA.
The information gathered during the MDCTCA will be compared to the results of the scheduled conventional invasive coronary angiogram.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
168
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Group 1
- Valvular heart disease (mitral stenosis, mitral regurgitation, aortic stenosis or aortic insufficiency) or
- Congenital heart disease (i.e. VSD, ASD, PDA) or
- Cardiomyopathy OR
Group 2
- Intermediate probability of coronary artery disease (probability of 10-90%) after clinical evaluation and traditional non-invasive testing
Exclusion Criteria:
- Age < 18 years
- Lack of consent
- Renal Insufficiency (GFR < 60 mL/min)
- Allergy to contrast agent
- Refractory angina requiring urgent/emergent coronary angiography (as per treating physician)
- Pregnancy or breast feeding
- Uncontrolled heart rate
- Previous CABG or PCI/Stent
- Chronic atrial fibrillation
- History of acute myocardial infarction, as defined by a creatine kinase (CK) level greater than 2 times normal with a troponin level above 4.
- Unable to perform 20 second breath-hold
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sensitivity and specificity of MDCTCA as compared to CICA
Time Frame: After both MDCTCA and CICA are completed
|
After both MDCTCA and CICA are completed
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Descriptive statistics (rates and proportions) will be calculated for the number of "avoidable" diagnostic cardiac catheterizations.
Time Frame: After both MDCTCA and CICA are completed
|
After both MDCTCA and CICA are completed
|
|
The accuracy of MDCTCA to CICA will be compared in categorizing patients inot single, double, triple vessel, left main disease or no coronary stenosis.
Time Frame: After both MDCTCA and CICA are completed
|
After both MDCTCA and CICA are completed
|
|
The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated.
Time Frame: After both MDCTCA and CICA are completed
|
After both MDCTCA and CICA are completed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Narinder Paul, MD, University Health Network, Toronto
- Study Chair: Michael Freeman, MD, Unity Health Toronto
- Principal Investigator: Alan Moody, MD, Sunnybrook Health Sciences Centre
- Principal Investigator: Benjamin Chow, MD, Ottawa Heart Institute Research Corporation
- Study Chair: Ronald Goeree, MA, Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 1, 2006
First Submitted That Met QC Criteria
September 1, 2006
First Posted (Estimate)
September 4, 2006
Study Record Updates
Last Update Posted (Estimate)
November 25, 2010
Last Update Submitted That Met QC Criteria
November 24, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HTA007-0603-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.