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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

September 1, 2006
November 24, 2010
September 2006
June 2009   (final data collection date for primary outcome measure)
Sensitivity and specificity of MDCTCA as compared to CICA [ Time Frame: After both MDCTCA and CICA are completed ] [ Designated as safety issue: No ]
Sensitivity and specificity of MDCTCA as compared to CICA
Complete list of historical versions of study NCT00371891 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Coronary Arteriosclerosis
  • Cardiomyopathies
  • Heart Defects, Congenital
  • Heart Valve Diseases
Procedure: Multidetector Computed Tomography Coronary Angiography
1 Multidetector Computed Tomography Coronary Angiography
Not Provided
Chow BJ, Freeman MR, Bowen JM, Levin L, Hopkins RB, Provost Y, Tarride JE, Dennie C, Cohen EA, Marcuzzi D, Iwanochko R, Moody AR, Paul N, Parker JD, O'Reilly DJ, Xie F, Goeree R. Ontario multidetector computed tomographic coronary angiography study: field evaluation of diagnostic accuracy. Arch Intern Med. 2011 Jun 13;171(11):1021-9. doi: 10.1001/archinternmed.2011.74. Epub 2011 Mar 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00371891
HTA007-0603-01
Yes
Ron Goeree, Programs for Assessment of Technology in Health (PATH) Research Institute
St. Joseph's Healthcare Hamilton
Not Provided
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
St. Joseph's Healthcare Hamilton
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP