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

January 25, 2012 updated by: Benjamin Chow, Ottawa Heart Institute Research Corporation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure the accuracy of CTA to SPECT for the diagnosis of CAD
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To examine the accuracy of CTA predicting the mode of treatment: Medical therapy or revascularization (PCI versus CABG)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Benjamin JW Chow, MD, FRCPC, Ottawa Heart Institute Research Corporation
  • Study Chair: Robert Beanlands, MD, Ottawa Heart Institute Research Corporation
  • Study Chair: Terrence Ruddy, MD, Univeristy of Ottawa Heart Institute
  • Study Chair: Carole Dennie, MD, The Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (Estimate)

March 21, 2007

Study Record Updates

Last Update Posted (Estimate)

January 26, 2012

Last Update Submitted That Met QC Criteria

January 25, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006360-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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