Clinical trial NCT00449826: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Non-ST-Elevation Myocardial Infarction
Unstable Angina
Keywords: ACS
Unstable Angina
NSTEMI
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2007-03-21
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Operating Characteristics of CTA
timeFrame: 1 month
Secondary outcomes:
measure: To compare the accuracy of CTA to CICA in predicting the mode of revascularization (PCI versus CABG) in NSTE-ACS patients.
timeFrame: 1 month
measure: To determine the number of "avoidable" CICA (i.e. those accurately designated to medical therapy or surgery with CTA).
timeFrame: 1 month
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Carole Dennie, MD
role: STUDY_DIRECTOR
affiliation: Ottawa Heart Institute Research Corporation
name: Derek So, MD
role: STUDY_DIRECTOR
affiliation: Univeristy of Ottawa Heart Institute
name: Chris Glvoer, MD
role: STUDY_DIRECTOR
affiliation: Ottawa Heart Institute Research Corporation
name: Benjamin JW Chow, MD
role: PRINCIPAL_INVESTIGATOR
References: