Design of the Rule Out Myocardial Ischemia/Infarction Using Computer Assisted Tomography: a multicenter randomized comparative effectiveness trial of cardiac computed tomography versus alternative triage strategies in patients with acute chest pain in the emergency department

Abstract

Although early cardiac computed tomographic angiography (CCTA) might improve the management of emergency department (ED) patients with acute chest pain, it could also result in increased testing, costs, and radiation exposure. ROMICAT II was a randomized comparative effectiveness trial enrolling patients 40 to 74 years old without known coronary artery disease who presented to the ED with chest pain but without ischemic electrocardiographic (ECG) changes or elevated initial troponin and who required further risk stratification. Overall, 1000 patients at 9 sites within the United States were randomized to either CCTA as the first diagnostic test following serial biomarkers or to standard of care, which included no testing or functional testing such as exercise ECG, stress radionuclide imaging, or stress echocardiography. Test results were provided to ED physicians, yet patient management was not driven by a study protocol in either arm. Data were collected on diagnostic testing, cardiac events, and cost of medical care for the index hospitalization and during the following 28 days. The primary end point was length of hospital stay. Secondary end points were cumulative radiation exposure, resource utilization, and costs of competing strategies. Tertiary end points were institutional, physician, and patient characteristics associated with primary and secondary outcomes. Rate of missed acute coronary syndrome within 28 days was the safety end point. The ROMICAT II will provide rigorous data on whether CCTA is more efficient than standard of care in the management of patients with acute chest pain at intermediate risk for acute coronary syndrome.

Trial registration: ClinicalTrials.gov NCT01084239.

Copyright © 2012 Mosby, Inc. All rights reserved.

Figures

Figure 1

ROMICAT II study design.

Figure 2

Projected LOS for ROMICAT II based on CT findings of CAD and LV function and prevalence of ACS in the ROMICAT I study. The projections were based on 356 patients with CT coronary and functional data sets from ROMICAT I study (12/368 patients had incomplete LV functional data sets and were excluded in the model). ROMICAT I was an observational study in which CT results were used to project the length of stay based on assumptions of patient management related to the CT findings. These data informed sample size and power calculation for the primary end point in the ROMICAT II trial.