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

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ClinicalTrials.gov Identifier: NCT00449826
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : January 26, 2012
Information provided by (Responsible Party):
Benjamin Chow, University of Ottawa Heart Institute

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Risk Stratification of Non ST Elevation ACS With Computed Tomographic Angiography (REACT)
Study Start Date : September 2006
Primary Completion Date : December 2008
Study Completion Date : December 2010

Intervention Details:
    Procedure: Computed Tomographic Angiography
    CT scan

Primary Outcome Measures :
  1. Operating Characteristics of CTA [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. 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 ]
  2. To determine the number of "avoidable" CICA (i.e. those accurately designated to medical therapy or surgery with CTA). [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449826

Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
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

Additional Information:
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
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by Benjamin Chow, University of Ottawa Heart Institute:
Unstable Angina

Additional relevant MeSH terms:
Myocardial Infarction
Acute Coronary Syndrome
Angina, Unstable
Non-ST Elevated Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms