Ignite Creation Date:
2024-05-05 @ 10:19 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01084239
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2010-01-07
Brief Title:
Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Rule Out Myocardial IschemiaInfarction by Computer Assisted Tomography
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROMICAT-II
Brief Summary:
The growing availability of cardiac computed tomography CT in emergency departments EDs across the US 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 performed 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 ie shorten length of hospital stay increase direct discharge rates from the ED decreasing healthcare costs and improving cost effectiveness while being safe
Detailed Description:
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 eg 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 US 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 performed a trial at 9 clinical sites and randomized 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
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 performed a trial at 9 clinical sites and randomized 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None