Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain
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|ClinicalTrials.gov Identifier: NCT00678639|
Recruitment Status : Completed
First Posted : May 15, 2008
Results First Posted : April 28, 2010
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Chest Pain||Other: Observation unit care, coupled with cardiac MRI||Not Applicable|
Almost half of patients presenting to the Emergency Department (ED) with possible cardiac chest pain are at intermediate risk for short term death or infarction. Most are admitted to the hospital for serial ECG's, cardiac biomarkers, cardiology consultation, and stress testing or coronary angiogram. However, the 2007 ACC/AHA guidelines suggest that these patients can be managed in an observation unit (OU). Recently, cardiac magnetic resonance imaging (CMR) has proven more accurate than traditional testing modalities for the diagnosis of acute coronary syndrome (ACS), and has also received endorsement from the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines. Immediate application of CMR in an OU may improve health care utilization compared to standard hospital admission for intermediate risk patients.
- Patients in an OU CMR protocol will have lower cost for the index hospitalization than standard care.
- An OU CMR protocol for patients with intermediate risk chest pain will significantly improve the frequency of correct cardiovascular admission decisions when compared to standard care.
110 ED patients at intermediate risk for short-term death or infarction, with nondiagnostic Electrocardiograms (ECG) and normal initial cardiac biomarkers, will be randomized to standard care or OU CMR protocols. Subjects in the OU CMR protocol will undergo CMR perfusion and stress testing, followed by serial biomarkers. Standard care subjects will be admitted for usual cardiac testing. ACS (infarction, death, coronary revascularization, unstable angina) will be assessed by evaluation of hospital course and phone follow-up at 30 days. Cost of hospital care will be compared among groups.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Cost Comparison of Cardiac MRI Use in ED Patients With Chest Pain|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Experimental: Emergency Department (ED) Observation unit
Emergency Department observation unit- Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
Other: Observation unit care, coupled with cardiac MRI
After Emergency Department (ED) evaluation, patients are randomized to Observation unit care or standard inpatient care. Patients in the observation unit will also undergo a stress cardiac MRI. Patients in the usual care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
No Intervention: Usual care
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
- Cost of Index Hospitalization [ Time Frame: Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours ]Index hospitalization refers to the hospital visit during which the participant was enrolled in the trial. The primary outcome is examining the cost for this visit.
- Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days [ Time Frame: 30 Days ]Participants with ACS and admitted or not experiencing ACS and discharged will be considered a correct admission decision. Remaining participants will be considered to have incorrect admission decisions.
- The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging [ Time Frame: Emergency Department (ED) arrival through hospital discharge ]The number of participants able to complete the planned imaging sequences will be measured.
- Number of Participants Who Utilized the Indicated Health Care Procedures [ Time Frame: 30d, 3mo, 6mo, and 1 year ]Measured as self report, assessed during telephone follow-up.
- Adverse Events During Magnetic Resonance Imaging (MRI) Scanning [ Time Frame: Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition. ]Any event leading to early termination of the MRI acquisition, or requiring intervention by a physician, will be considered an adverse event related to MRI, excluding physician termination of image acquisition due to concerns of cardiac ischemia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678639
|United States, North Carolina|
|Wake Forest University Baptist Medical Center - Emergency Department|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Chadwick D Miller, MD||WFUBMC|