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

Primary Purpose

Coronary Arteriosclerosis, Cardiomyopathies, Heart Defects, Congenital

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Multidetector Computed Tomography Coronary Angiography

About this trial

This is an interventional diagnostic trial for Coronary Arteriosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Ottawa Heart Institute
Sunnybrook Health Sciences Centre
St. Michael's Hospital
University Health Network

Outcomes

Primary Outcome Measures

Sensitivity and specificity of MDCTCA as compared to CICA

Secondary Outcome Measures

Descriptive statistics (rates and proportions) will be calculated for the number of "avoidable" diagnostic cardiac catheterizations.

The accuracy of MDCTCA to CICA will be compared in categorizing patients inot single, double, triple vessel, left main disease or no coronary stenosis.

The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated.

Full Information

NCT ID

NCT00371891

First Posted

September 1, 2006

Last Updated

November 24, 2010

Sponsor

St. Joseph's Healthcare Hamilton

1. Study Identification

Unique Protocol Identification Number

NCT00371891

Brief Title

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

Official Title

The Ontario Multidetector Computed Tomography (MDCT) Coronary Angiography Study (OMCAS)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Arteriosclerosis, Cardiomyopathies, Heart Defects, Congenital, Heart Valve Diseases

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Multidetector Computed Tomography Coronary Angiography

Intervention Description

1 Multidetector Computed Tomography Coronary Angiography

Primary Outcome Measure Information:

Title

Sensitivity and specificity of MDCTCA as compared to CICA

Time Frame

After both MDCTCA and CICA are completed

Secondary Outcome Measure Information:

Title

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

Title

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

Title

The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated.

Time Frame

After both MDCTCA and CICA are completed

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: