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Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)

This study has been completed.
Sponsor:
Information provided by:
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00371891
First received: September 1, 2006
Last updated: November 24, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Arteriosclerosis
Cardiomyopathies
Heart Defects, Congenital
Heart Valve Diseases
 Procedure: Multidetector Computed Tomography Coronary Angiography
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Ontario Multidetector Computed Tomography (MDCT) Coronary Angiography Study (OMCAS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Sensitivity and specificity of MDCTCA as compared to CICA [ Time Frame: After both MDCTCA and CICA are completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated. [ Time Frame: After both MDCTCA and CICA are completed ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: September 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Multidetector Computed Tomography Coronary Angiography
    1 Multidetector Computed Tomography Coronary Angiography
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371891

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
Study Chair: Michael Freeman, MD St. Michael's Hospital, Toronto
Principal Investigator: Alan Moody, MD Sunnybrook Health Sciences Centre
Principal Investigator: Benjamin Chow, MD University of Ottawa Heart Institute
Study Chair: Ronald Goeree, MA Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University
Principal Investigator: Narinder Paul, MD University Health Network, Toronto
  More Information

No publications provided by St. Joseph's Healthcare Hamilton

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ron Goeree, Programs for Assessment of Technology in Health (PATH) Research Institute
ClinicalTrials.gov Identifier: NCT00371891     History of Changes
Other Study ID Numbers: HTA007-0603-01
Study First Received: September 1, 2006
Last Updated: November 24, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Heart Defects, Congenital
Heart Valve Diseases
Cardiomyopathies
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Cardiovascular Abnormalities

ClinicalTrials.gov processed this record on June 18, 2013