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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449826
• Other study ID #: UOHI 2006361-01H
• Status: Completed
• Phase: N/A
• First received: March 20, 2007
• Last updated: January 25, 2012
• Start date: September 2006
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Computed Tomographic Angiography
CT scan

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operating Characteristics of CTA		1 month	No
Secondary	To compare the accuracy of CTA to CICA in predicting the mode of revascularization (PCI versus CABG) in NSTE-ACS patients.		1 month	No
Secondary	To determine the number of "avoidable" CICA (i.e. those accurately designated to medical therapy or surgery with CTA).		1 month	No

External Links

•   University of Ottawa Heart Institute