Risk Stratification of Non ST Elevation ACS With Computed Tomographic Angiography (REACT)

January 25, 2012 updated by: Benjamin Chow, Ottawa Heart Institute Research Corporation

The purpose of this project is to examine the effectiveness of computed tomographic angiography (CTA) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). People who are hospitalized with this situation often require an angiogram to assess the heart and its arteries.

Recent advancements in technology have enabled CTA to clearly define coronary artery anatomy with great accuracy and to guide treatment strategies in select patient populations. We are investigating that CTA may be used, as an alternative to conventional angiograms, for the risk stratification of patients with high risk NSTE-ACS.

Patients eligible for the study will be high risk NSTE-ACS and awaiting an angiogram. Enrolled patients will undergo CTA prior to the angiogram. With each CTA the patient will be injected with a small dose of an X-ray dye and will be asked to lie still on the "scanning bed" for a period of 5-10 minutes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Computed Tomographic Angiography

Study Type

Interventional

Enrollment (Actual)

107

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Ottawa, Ontario, Canada, K1Y 4W7
    - University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

High risk ACS
1. Angina [accelerating pattern or prolonged episode (> 20 minutes) or recurrent episode at rest or with minimal effort within preceding 24 hours]; and (13)
2. Elevated Troponin - T (≥0.1 ug/L) or ECG changes consistent with ischemia [ST depression ≥ 0.1 mV, transient ST segment elevation ≥ 0.1 mV (< 20 minutes)]) (11;13)
Planned conventional invasive coronary angiography

Exclusion Criteria:

Age < 18 years or lack of consent
Renal Insufficiency (GFR < 60 ml/min)
Allergy to contrast agent
Refractory angina requiring urgent/emergent coronary angiography (as per treating physician)
Contraindication to radiation exposure (e.g. pregnancy)
Uncontrolled HR
Previous CABG or PCI/Stent
Atrial fibrillation, frequent atrial or ventricular ectopy (> 1 / minute)
Unable to perform 20 second breath-hold

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Operating Characteristics of CTA Time Frame: 1 month	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare the accuracy of CTA to CICA in predicting the mode of revascularization (PCI versus CABG) in NSTE-ACS patients. Time Frame: 1 month	1 month
To determine the number of "avoidable" CICA (i.e. those accurately designated to medical therapy or surgery with CTA). Time Frame: 1 month	1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Investigators

Study Director: Carole Dennie, MD, The Ottawa Hospital
Study Director: Derek So, MD, Ottawa Heart Institute Research Corporation
Study Director: Chris Glvoer, MD, Univeristy of Ottawa Heart Institute
Principal Investigator: Benjamin JW Chow, MD, Ottawa Heart Institute Research Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

University of Ottawa Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria