Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Sensitivity and specificity of MDCTCA as compared to CICA [ Time Frame: After both MDCTCA and CICA are completed ]
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 ]
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 ]
The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated. [ Time Frame: After both MDCTCA and CICA are completed ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Valvular heart disease (mitral stenosis, mitral regurgitation, aortic stenosis or aortic insufficiency) or
Congenital heart disease (i.e. VSD, ASD, PDA) or
Intermediate probability of coronary artery disease (probability of 10-90%) after clinical evaluation and traditional non-invasive testing
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.