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NCT Number: NCT00371891

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

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.

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Key information

Conditions

Coronary Arteriosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiomyopathies Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Artery Disease Coronary Disease Heart Defects, Congenital Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Ottawa Heart Institute, Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidetector Computed Tomography Coronary Angiography

Procedure

1 Multidetector Computed Tomography Coronary Angiography

Primary outcomes

  1. Sensitivity and specificity of MDCTCA as compared to CICA

    Time frame: After both MDCTCA and CICA are completed

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: After both MDCTCA and CICA are completed

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 4, 2006
Registry last updated
Nov 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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