Clinical trial NCT00371891: Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)
Official title: The Ontario Multidetector Computed Tomography (MDCT) Coronary Angiography Study (OMCAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Arteriosclerosis
Cardiomyopathies
Heart Defects, Congenital
Heart Valve Diseases
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2006-09-04
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of MDCTCA as compared to CICA
timeFrame: After both MDCTCA and CICA are completed
Secondary outcomes:
measure: Descriptive statistics (rates and proportions) will be calculated for the number of "avoidable" diagnostic cardiac catheterizations.
timeFrame: After both MDCTCA and CICA are completed
measure: The accuracy of MDCTCA to CICA will be compared in categorizing patients inot single, double, triple vessel, left main disease or no coronary stenosis.
timeFrame: After both MDCTCA and CICA are completed
measure: The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated.
timeFrame: After both MDCTCA and CICA are completed
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Michael Freeman, MD
role: STUDY_CHAIR
affiliation: Sunnybrook Health Sciences Centre
name: Alan Moody, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Benjamin Chow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University
name: Ronald Goeree, MA
role: STUDY_CHAIR
affiliation: University Health Network, Toronto
name: Narinder Paul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.