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

NCT ID: NCT00371891

Last Updated: 2010-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Coronary Arteriosclerosis Cardiomyopathies Heart Defects, Congenital Heart Valve Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Multidetector Computed Tomography Coronary Angiography

1 Multidetector Computed Tomography Coronary Angiography

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Programs for Assessment of Technology in Health (PATH) Research Institute

Principal Investigators

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Michael Freeman, MD

Role: STUDY_CHAIR

Unity Health Toronto

Alan Moody, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Benjamin Chow, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Ronald Goeree, MA

Role: STUDY_CHAIR

Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University

Narinder Paul, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 21403014 (View on PubMed)

Other Identifiers

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HTA007-0603-01

Identifier Type: -

Identifier Source: org_study_id