Rule Out Myocardial Ischemia/Infarction by Computer Assisted Tomography (ROMICAT-II)
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April 2010 – March 2012
May 22, 2015
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Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
The ROMICAT-II trial compared the effectiveness of a coronary computed tomographic angiography (CCTA) based evaluation strategy with that of standard evaluation in the emergency department in reducing hospital stay length for patients with symptoms suggestive of an acute coronary syndrome.
Treatment of patients with acute chest pain but an inconclusive initial evaluation with the use of biomarkers and electrocardiographic testing is often diagnostically challenging and inefficient. The majority of patients with acute coronary syndromes have underlying coronary artery disease. Contrast-enhanced CCTA has high sensitivity and specificity for the detection of clinically significant coronary artery disease, as compared with invasive coronary angiography, in patients in stable condition with suspected or known coronary artery disease.
Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography (ROMICAT-I), a blinded observational study involving patients in the emergency department with suspected acute coronary syndromes, and other studies have shown that normal findings on CCTA have a very high negative predictive value for ruling out acute coronary syndromes during the index hospitalization and the occurrence of major adverse cardiovascular events over the next 2 years. The results of two previous randomized, multicenter trials suggest that CCTA may facilitate safe and earlier triage of low-risk patients and that CCTA can rule out coronary artery disease faster than stress myocardial-perfusion imaging. However, imaging the coronary anatomy with CCTA can involve more procedures and greater costs than functional testing. Thus, ROMITCAT-II sought to evaluate the effectiveness of incorporating CCTA into an evaluation strategy in the emergency department.
Eligibility criteria were chosen according to the ROMICAT-I study, with the goal of enrolling a population with a similar prevalence of acute coronary syndromes (approximately 8%). Eligible patients were 40 to 74 years of age, presented to the emergency department with chest pain (or the anginal equivalent) of at least 5 minutes in duration within the last 24 hours, were in sinus rhythm, and warranted further risk stratification to rule out acute coronary syndromes. Major exclusion criteria were a history of known coronary artery disease, new diagnostic ischemic changes on the initial ECG, an initial troponin level in excess of the 99th percentile of the local assay, impaired renal function, hemodynamic or clinical instability, known allergy to an iodinated contrast agent, a BMI greater than 40, or currently symptomatic asthma.
1000 subjects were enrolled with 501 assigned to the CCTA group and 499 assigned to the standard evaluation group. 987 subjects completed follow-up at 28 days.
Subjects were randomly assigned at their initial evaluation in the emergency department in a 1:1 ratio to either include CCTA as part of the initial evaluation or receive the standard evaluation strategy. Additional care was not mandated by the study protocol in either randomization group. To ascertain potentially undetected acute coronary syndromes and as a safety measure, patients discharged within 24 hours after presentation in the emergency department were contacted by telephone within 72 hours to assess their clinical status. A follow-up telephone call to all patients was also conducted 28 days after discharge. During telephone calls, information on repeat visits to the emergency department or re-hospitalizations for recurrent chest pain (including diagnostic testing, interventions, and clinical events during follow-up) was obtained and verified by the collection of medical records.
The primary outcome was the length of the hospital stay, defined as the time from presentation in the emergency department to the time of the discharge order. Secondary outcomes included rates of discharge from the emergency department, major adverse cardiovascular events at 28 days, and cumulative costs. Safety end points were undetected acute coronary syndromes.
In patients in the emergency department with symptoms suggestive of acute coronary syndromes, incorporating CCTA into a triage strategy improved the efficiency of clinical decision making, as compared with a standard evaluation in the emergency department, but it resulted in an increase in downstream testing and radiation exposure with no decrease in the overall costs of care. The average length of hospital stay for patients in the CCTA group was significantly less (7.6 hours) than the standard evaluation group.
N Engl J Med. 2012 Jul 26;367(4):299-308.
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