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

NCT00371891 | Completed Phase 4 DMC

• 1 other identifier: HTA007-0603-01
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of MDCTCA as compared to CICA

  After both MDCTCA and CICA are completed

Secondary Outcomes (3)

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

  After both MDCTCA and CICA are completed

• 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

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

  After both MDCTCA and CICA are completed

Interventions

Multidetector Computed Tomography Coronary Angiography PROCEDURE

1 Multidetector Computed Tomography Coronary Angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (4)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• 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.

  PMID: 21403014 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Cardiomyopathies; Heart Defects, Congenital; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael Freeman, MD

  Unity Health Toronto

  STUDY CHAIR

• Alan Moody, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Benjamin Chow, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

• Ronald Goeree, MA

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

  STUDY CHAIR

• Narinder Paul, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2006
• First Posted: September 4, 2006
• Study Start: September 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 25, 2010

Record last verified: 2010-11

Locations

CA (4)