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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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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