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

Phase 4

Completed

• Conditions: Coronary Arteriosclerosis; Cardiomyopathies; Heart Defects, Congenital; Heart Valve Diseases

• Registration Number: NCT00371891
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-01
• Study First Submitted QC: 2006-09-01
• Study First Posted: 2006-09-04
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-24
• Last Update Posted: 2010-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of MDCTCA as compared to CICA	After both MDCTCA and CICA are completed

Secondary Outcome Measures

Name	Time	Method
Descriptive statistics (rates and proportions) will be calculated for the number of "avoidable" diagnostic cardiac catheterizations.	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.	After both MDCTCA and CICA are completed
The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated.	After both MDCTCA and CICA are completed

Trial Locations

Locations (4)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada