Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)
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| First Received Date ICMJE | September 1, 2006 | ||||||||||||||||||||
| Last Updated Date | November 24, 2010 | ||||||||||||||||||||
| Start Date ICMJE | September 2006 | ||||||||||||||||||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Sensitivity and specificity of MDCTCA as compared to CICA [ Time Frame: After both MDCTCA and CICA are completed ] [ Designated as safety issue: No ] | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE |
Sensitivity and specificity of MDCTCA as compared to CICA | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00371891 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS) | ||||||||||||||||||||
| Official Title ICMJE | The Ontario Multidetector Computed Tomography (MDCT) Coronary Angiography Study (OMCAS) | ||||||||||||||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Phase | Phase 4 | ||||||||||||||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Multidetector Computed Tomography Coronary Angiography
1 Multidetector Computed Tomography Coronary Angiography |
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| Study Arm (s) | Not Provided | ||||||||||||||||||||
| Publications * | 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. Epub 2011 Mar 14. | ||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||
| Enrollment ICMJE | 168 | ||||||||||||||||||||
| Completion Date | June 2009 | ||||||||||||||||||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Group 1
Group 2
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT00371891 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | HTA007-0603-01 | ||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||
| Responsible Party | Ron Goeree, Programs for Assessment of Technology in Health (PATH) Research Institute | ||||||||||||||||||||
| Study Sponsor ICMJE | St. Joseph's Healthcare Hamilton | ||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | St. Joseph's Healthcare Hamilton | ||||||||||||||||||||
| Verification Date | November 2010 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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