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

NCT00449826 | Completed

• 1 other identifier: UOHI 2006361-01H
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ACS; Unstable Angina; NSTEMI

Outcome Measures

Primary Outcomes (1)

• Operating Characteristics of CTA

  1 month

Secondary Outcomes (2)

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

  1 month

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

  1 month

Interventions

Computed Tomographic Angiography PROCEDURE

CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Links

• University of Ottawa Heart Institute

MeSH Terms

Conditions

Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• 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

  STUDY DIRECTOR

• Benjamin JW Chow, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

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: Dr Benjamin Chow

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

CA (1)