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

Coronary Arteriosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371891
• Other study ID #: HTA007-0603-01
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2006
• Last updated: November 24, 2010
• Start date: September 2006
• Est. completion date: June 2009

Study information

• Verified date: November 2010
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arteriosclerosis
• Cardiomyopathies
• Congenital Abnormalities
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Heart Defects, Congenital
• Heart Valve Diseases
• Myocardial Ischemia

Intervention

Procedure:
• Multidetector Computed Tomography Coronary Angiography
1 Multidetector Computed Tomography Coronary Angiography

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of MDCTCA as compared to CICA		After both MDCTCA and CICA are completed	No
Secondary	Descriptive statistics (rates and proportions) will be calculated for the number of "avoidable" diagnostic cardiac catheterizations.		After both MDCTCA and CICA are completed	No
Secondary	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	No
Secondary	The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated.		After both MDCTCA and CICA are completed	No