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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Chow, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT00449826
First received: March 20, 2007
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Non-ST-Elevation Myocardial Infarction
Unstable Angina
 Procedure: Computed Tomographic Angiography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Risk Stratification of Non ST Elevation ACS With Computed Tomographic Angiography (REACT)

Resource links provided by NLM:

MedlinePlus related topics: Angina Heart Attack
U.S. FDA Resources

Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • Operating Characteristics of CTA [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To determine the number of "avoidable" CICA (i.e. those accurately designated to medical therapy or surgery with CTA). [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: September 2006
Study Completion Date: December 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Computed Tomographic Angiography
    CT scan
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449826

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
University of Ottawa Heart Institute
Investigators
Study Director: Carole Dennie, MD The Ottawa Hospital
Study Director: Derek So, MD University of Ottawa Heart Institute
Study Director: Chris Glvoer, MD Univeristy of Ottawa Heart Institute
Principal Investigator: Benjamin JW Chow, MD University of Ottawa Heart Institute
  More Information

Additional Information:
University of Ottawa Heart Institute  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Benjamin Chow, Dr Benjamin Chow, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT00449826     History of Changes
Other Study ID Numbers: UOHI 2006361-01H
Study First Received: March 20, 2007
Last Updated: January 25, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Ottawa Heart Institute:
ACS
Unstable Angina
NSTEMI

Additional relevant MeSH terms:
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on October 01, 2012