Clinical trial NCT00449943: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Cardiac Invasive Catheterization Angiography
Single Photon Emission Computed Tomography
Computed Tomography Angiography
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2007-03-21
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


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

Primary outcomes:
measure: To measure the accuracy of CTA to SPECT for the diagnosis of CAD
timeFrame: 1 year
Secondary outcomes:
measure: To examine the accuracy of CTA predicting the mode of treatment: Medical therapy or revascularization (PCI versus CABG)
timeFrame: 1 year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Benjamin JW Chow, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Robert Beanlands, MD
role: STUDY_CHAIR
affiliation: Univeristy of Ottawa Heart Institute
name: Terrence Ruddy, MD
role: STUDY_CHAIR
affiliation: The Ottawa Hospital
name: Carole Dennie, MD
role: STUDY_CHAIR
References: