Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography (ROMICAT-II)
The growing availability of cardiac computed tomography (CT)* in emergency departments (EDs) across the U.S. expands the opportunities for its clinical application, but also heightens the need to define its appropriate use in the evaluation of patients with acute chest pain. To address this need, we propose to perform a randomized diagnostic trial (RDT) to determine whether integrating cardiac CT, along with the information it provides on coronary artery disease (CAD) and left ventricular (LV) function, can improve the efficiency of the management of these patients (i.e. shorten length of hospital stay, increase direct discharge rates from the ED, decreasing healthcare costs and improving cost effectiveness while being safe).
Acute Coronary Syndrome
Unstable Angina Pectoris
Radiation: Cardiac Computed Tomography
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Rule Out Myocardial Ischemia/Infarction by Computer Assisted Tomography|
- To determine whether length of hospital stay is significantly reduced in the CT arm compared to the comparator arm, that includes other commonly used risk stratification tests (ETT, SPECT, stress ECHO). [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: Yes ]
- time to diagnosis [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: Yes ]
- healthcare utilization [ Time Frame: Duration of stay in the hospital during the initial visit and 28 days after enrollment ] [ Designated as safety issue: Yes ]
- MACE [ Time Frame: Duration of stay in the hospital during the initial visit and 28 days after enrollment ] [ Designated as safety issue: Yes ]
- cost-effectiveness [ Time Frame: Duration of stay in the hospital during the initial visit and 28 days after enrollment ] [ Designated as safety issue: No ]
- Rate of ED discharge [ Time Frame: Duration of stay in the hospital during the initial visit ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
No Intervention: Standard of care
Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
Experimental: Cardiac CT
Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.
Radiation: Cardiac Computed Tomography
A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
Patients with acute chest pain and normal or non-diagnostic electrocardiograms (ECGs) represent a cohort whose management is notably inefficient and diagnostically challenging. Because in less than 30% of EDs diagnostic testing (e.g. nuclear imaging, echocardiography, and exercise treadmill ECG) that would allow physicians to rule out the occurrence of myocardial ischemia is performed as part of the initial evaluation, most of these patients are hospitalized for 24 to 36 hours to exclude the presence of acute coronary syndrome (ACS). Of the six million acute chest pain patients admitted each year in the U.S. under these conditions, less than 10% of them ultimately receive a diagnosis of ACS at discharge. Moreover, inpatient care for negative evaluations imparts an economic burden in excess of $8 billion annually.
Since acute myocardial ischemia and necrosis are rare in the absence of coronary artery disease, a technology that reliably identifies CAD may allow physicians to discharge chest pain patients directly from the ED. Cardiac CT is a safe, high-speed, noninvasive imaging technique that accurately detects coronary atherosclerotic plaque and stenosis, and also allows physicians to assess global and regional LV function.
Observational studies have demonstrated that approximately 40% of acute chest pain patients have no evidence of atherosclerosis on cardiac CT, and that an additional 30% have no evidence of hemodynamically significant (>50%) coronary artery stenosis. Both of these criteria are powerful predictors of the absence of both ACS and major adverse cardiovascular events (negative predictive value [NPV] of 98%). The specificity of cardiac CT is further increased when global and regional LV function is normal. Several studies have demonstrated that cardiac CT, with its high NPV, can be effectively used to rule out ACS, but little is known about the willingness ability of ED physicians to use this information to augment patient management.
We therefore propose to perform a trial that will mobilize seven clinical sites and randomize 1000 patients with acute chest pain and normal or non-diagnostic ECGs, to receive either standard ED evaluation (no intervention) or a cardiac CT (experimental) in the evaluation of acute chest pain in the emergency room. (Rule Out Myocardial Infarction using Computer Assisted Computed Tomography [ROMICAT II]).
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Udo Hoffmann, MD, MPH||Massachusetts General Hospital|