Comparison of Cardiac Computed Tomographic Angiography (CTA) to Tc-99m Single Photon Emission Computed Tomography (SPECT)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Computed Tomographic Angiography
Myocardial Perfusion Imaging Scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Cardiac Invasive Catheterization Angiography, Single Photon Emission Computed Tomography, Computed Tomography Angiography
Eligibility 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
Sites / Locations
- University of Ottawa Heart Institute
Outcomes
Primary Outcome Measures
To measure the accuracy of CTA to SPECT for the diagnosis of CAD
Secondary Outcome Measures
To examine the accuracy of CTA predicting the mode of treatment: Medical therapy or revascularization (PCI versus CABG)
Full Information
NCT ID
NCT00449943
First Posted
March 20, 2007
Last Updated
January 25, 2012
Sponsor
Ottawa Heart Institute Research Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00449943
Brief Title
Comparison of Cardiac Computed Tomographic Angiography (CTA) to Tc-99m Single Photon Emission Computed Tomography (SPECT)
Official Title
Comparison of Cardiac Computed Tomographic Angiography (CTA) to Tc-99m Single Photon Emission Computed Tomography (SPECT)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Cardiac Invasive Catheterization Angiography, Single Photon Emission Computed Tomography, Computed Tomography Angiography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Computed Tomographic Angiography
Intervention Description
CT scan
Intervention Type
Procedure
Intervention Name(s)
Myocardial Perfusion Imaging Scan
Intervention Description
SPECT
Primary Outcome Measure Information:
Title
To measure the accuracy of CTA to SPECT for the diagnosis of CAD
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To examine the accuracy of CTA predicting the mode of treatment: Medical therapy or revascularization (PCI versus CABG)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin JW Chow, MD, FRCPC
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Beanlands, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Terrence Ruddy, MD
Organizational Affiliation
Univeristy of Ottawa Heart Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carole Dennie, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.ottawaheart.ca
Description
University of Ottawa Heart Institute
Learn more about this trial
Comparison of Cardiac Computed Tomographic Angiography (CTA) to Tc-99m Single Photon Emission Computed Tomography (SPECT)
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