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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449943
• Other study ID #: 2006360-01H
• Status: Completed
• Phase: N/A
• First received: March 20, 2007
• Last updated: January 25, 2012
• Start date: September 2006
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Computed Tomographic Angiography
CT scan
• Myocardial Perfusion Imaging Scan
SPECT

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the accuracy of CTA to SPECT for the diagnosis of CAD		1 year	No
Secondary	To examine the accuracy of CTA predicting the mode of treatment: Medical therapy or revascularization (PCI versus CABG)		1 year	No

External Links

•   University of Ottawa Heart Institute