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OpenTrials
Completed

NCT Number: NCT00449826

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

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.

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Key information

Conditions

Acute Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Non-ST-Elevation Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Unstable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Computed Tomographic Angiography

Procedure

CT scan

Primary outcomes

  1. Operating Characteristics of CTA

    Time frame: 1 month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Mar 21, 2007
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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