NCT00449943

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

2.3 years

First QC Date

March 20, 2007

Last Update Submit

January 25, 2012

Conditions

Keywords

Cardiac Invasive Catheterization AngiographySingle Photon Emission Computed TomographyComputed Tomography Angiography

Outcome Measures

Primary Outcomes (1)

  • To measure the accuracy of CTA to SPECT for the diagnosis of CAD

    1 year

Secondary Outcomes (1)

  • To examine the accuracy of CTA predicting the mode of treatment: Medical therapy or revascularization (PCI versus CABG)

    1 year

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred for Tc-99m SPECT or CTA; or
  • Patients referred for CICA without preceding (\< 12 months) MPI or CTA

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Benjamin JW Chow, MD, FRCPC

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 21, 2007

Study Start

September 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2010

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations