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Comparison of Cardiac Computed Tomographic Angiography (CTA) to Tc-99m Single Photon Emission Computed Tomography (SPECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Chow, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT00449943
First received: March 20, 2007
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

Cardiovascular disease and ischemic heart disease is the #1 killer in Canada. Currently, Cardiac invasive catheterization angiography (CICA) is the gold standard for the assessment of the arteries in the heart. However, cardiac catheterization has risks which prohibit its use in all patients. These risks include: death, heart attack, stroke and bleeding. Cardiac computed tomography angiography (CTA) is a new non-invasive technology which may enable the evaluation of patients' coronary anatomy without exposing patients to the risks of invasive cardiac catheterization.

The purpose of this project is to compare CT angiography (CTA) to Tc-99m single photon emission computed tomography (Tc-99m SPECT)

We will enroll patients who are waiting for a CICA or who have been referred for a TC-99m SPECT or CTA scans at the University of Ottawa Heart Institute. Consenting patients who are waiting for a CICA will have both a CTA and a Tc-99m SPECT scan. Consenting patients referred for a CTA or Tc-99m SPECT will have both the CTA and Tc-99m SPECT in a random order but not CICA (unless ordered by your physician).


Condition Intervention
Coronary Artery Disease
 Procedure: Computed Tomographic Angiography
Procedure: Myocardial Perfusion Imaging Scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Cardiac Computed Tomographic Angiography (CTA) to Tc-99m Single Photon Emission Computed Tomography (SPECT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • To measure the accuracy of CTA to SPECT for the diagnosis of CAD [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the accuracy of CTA predicting the mode of treatment: Medical therapy or revascularization (PCI versus CABG) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: September 2006
Study Completion Date: December 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Computed Tomographic Angiography
    CT scan
    Procedure: Myocardial Perfusion Imaging Scan
    SPECT
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred for Tc-99m SPECT or CTA; or
  • Patients referred for CICA without preceding (< 12 months) MPI or CTA

Exclusion Criteria:

  • Previous revascularization (PCI or CABG)
  • Age < 18 years or lack of consent
  • Renal Insufficiency (GFR < 60 ml/min)
  • Allergy or contraindication to contrast agent or dipyridamole
  • Refractory angina requiring urgent/emergent coronary angiography
  • Contraindication to radiation exposure (e.g. pregnancy)
  • Uncontrolled HR
  • Atrial fibrillation, frequent atrial or ventricular ectopy (> 1/minute)
  • Unable to perform 10 second breath-hold
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449943

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
University of Ottawa Heart Institute
Investigators
Principal Investigator: Benjamin JW Chow, MD, FRCPC University of Ottawa Heart Institute
Study Chair: Robert Beanlands, MD University of Ottawa Heart Institute
Study Chair: Terrence Ruddy, MD Univeristy of Ottawa Heart Institute
Study Chair: Carole Dennie, MD The Ottawa Hospital
  More Information

Additional Information:
University of Ottawa Heart Institute  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Benjamin Chow, MD, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT00449943     History of Changes
Other Study ID Numbers: 2006360-01H
Study First Received: March 20, 2007
Last Updated: January 25, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Ottawa Heart Institute:
Cardiac Invasive Catheterization Angiography
Single Photon Emission Computed Tomography
Computed Tomography Angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013