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

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ClinicalTrials.gov Identifier: NCT00371891
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : November 25, 2010
Sponsor:
Information provided by:
St. Joseph's Healthcare Hamilton

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Arteriosclerosis Cardiomyopathies Heart Defects, Congenital Heart Valve Diseases Procedure: Multidetector Computed Tomography Coronary Angiography Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Ontario Multidetector Computed Tomography (MDCT) Coronary Angiography Study (OMCAS)
Study Start Date : September 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Arms and Interventions
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Intervention Details:
  • Procedure: Multidetector Computed Tomography Coronary Angiography
    1 Multidetector Computed Tomography Coronary Angiography

Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity and specificity of MDCTCA as compared to CICA [ Time Frame: After both MDCTCA and CICA are completed ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated. [ Time Frame: After both MDCTCA and CICA are completed ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371891


Locations
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Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
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Study Chair: Michael Freeman, MD St. Michael's Hospital, 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
Principal Investigator: Narinder Paul, MD University Health Network, Toronto
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ron Goeree, Programs for Assessment of Technology in Health (PATH) Research Institute
ClinicalTrials.gov Identifier: NCT00371891    
Other Study ID Numbers: HTA007-0603-01
First Posted: September 4, 2006    Key Record Dates
Last Update Posted: November 25, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Cardiomyopathies
Arteriosclerosis
Heart Valve Diseases
Coronary Artery Disease
Myocardial Ischemia
Heart Defects, Congenital
Congenital Abnormalities
 Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease
Cardiovascular Abnormalities