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

St. Joseph's Healthcare Hamilton

Status and phase

Completed

Phase 4

Conditions

Heart Defects, Congenital

Heart Valve Diseases

Coronary Arteriosclerosis

Cardiomyopathies

Treatments

Procedure: Multidetector Computed Tomography Coronary Angiography

Study type

Interventional

Funder types

Other

Identifiers

NCT00371891

HTA007-0603-01

Details and patient eligibility

About

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.

Enrollment

168 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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