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

Primary Purpose

Acute Coronary Syndrome, Non-ST-Elevation Myocardial Infarction, Unstable Angina

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Computed Tomographic Angiography

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring ACS, Unstable Angina, NSTEMI

Eligibility Criteria

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

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

Sites / Locations

University of Ottawa Heart Institute

Outcomes

Primary Outcome Measures

Operating Characteristics of CTA

Secondary Outcome Measures

To compare the accuracy of CTA to CICA in predicting the mode of revascularization (PCI versus CABG) in NSTE-ACS patients.

To determine the number of "avoidable" CICA (i.e. those accurately designated to medical therapy or surgery with CTA).

Full Information

NCT ID

NCT00449826

First Posted

March 20, 2007

Last Updated

January 25, 2012

Sponsor

Ottawa Heart Institute Research Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00449826

Brief Title

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

Official Title

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

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Non-ST-Elevation Myocardial Infarction, Unstable Angina

Keywords

ACS, Unstable Angina, NSTEMI

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

Primary Outcome Measure Information:

Title

Operating Characteristics of CTA

Time Frame

1 month

Secondary Outcome Measure Information:

Title

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

Title

To determine the number of "avoidable" CICA (i.e. those accurately designated to medical therapy or surgery with CTA).

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: High risk ACS Angina [accelerating pattern or prolonged episode (> 20 minutes) or recurrent episode at rest or with minimal effort within preceding 24 hours]; and (13) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carole Dennie, MD

Organizational Affiliation

The Ottawa Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Derek So, MD

Organizational Affiliation

Ottawa Heart Institute Research Corporation

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Chris Glvoer, MD

Organizational Affiliation

Univeristy of Ottawa Heart Institute

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Benjamin JW Chow, MD

Organizational Affiliation

Ottawa Heart Institute Research Corporation

Official's Role

Principal Investigator

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

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

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