Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Chadwick Miller, Wake Forest University Health Sciences

ClinicalTrials.gov Identifier:

NCT00678639

First received: May 8, 2008

Last updated: February 10, 2017

Last verified: February 2017

History of Changes

Purpose

The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department. It compares receiving treatment in an observation unit with admission to the hospital. Patients treated in the observation unit will undergo cardiac Magnetic Resonance Imaging (MRI) testing. Patients treated with hospital admission will undergo the testing their doctor determines is best for them. All patients will undergo follow up to find out if they have had any heart related events.

Condition	Intervention
Acute Coronary Syndrome Chest Pain	Other: Observation unit care, coupled with cardiac MRI


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Randomized Cost Comparison of Cardiac MRI Use in ED Patients With Chest Pain

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain MRI Scans

U.S. FDA Resources

Further study details as provided by Chadwick Miller, Wake Forest University Health Sciences:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Enrollment:	110
Study Start Date:	January 2008
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Detailed Description:

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.

Research hypotheses:

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.

Methods summary:

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater than or equal to 18 years of age at the time of enrollment
Chest discomfort or other symptoms consistent with possible Acute Coronary Syndrome (ACS) as indicated by the treating physician after obtaining an Electrocardiogram (ECG) and cardiac biomarkers for the patient's evaluation
Patient requires an inpatient evaluation for their chest pain
The treating physician feels the patient could be discharged home if cardiac disease was excluded
Thrombolysis in Myocardial Infarction (TIMI) risk score ≥ 2 OR physician clinical impression of intermediate or high likelihood that the symptoms represent ACS
Negative pregnancy test (if sexually active, female, and of childbearing age)

Exclusion Criteria:

Initial troponin I > 1.0 ng/ml
New ST-segment elevation on any electrocardiogram (≥ 1 mV)
New ST-segment depression on any electrocardiogram (≥ 2 mV)
Unable to lie flat
Hypotension (systolic < 90 mm Hg)
Contra-indications to MRI(Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, claustrophobia)
Patient refusal of medical record review and telephone follow-up at 30 days
Terminal diagnosis with life expectancy less than 3 months
Pregnancy per patient report or positive pregnancy test (Center for Medicare & Medicaid Services (CMS) exclusion criteria)
Renal insufficiency(done prior to enrollment)or end stage renal disease
Chronic liver disease (ex. hepatitis, cirrhosis)
History of liver, heart, or kidney transplant

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678639

Locations


United States, North Carolina
Wake Forest University Baptist Medical Center - Emergency Department
Winston Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Chadwick Miller

Investigators


Principal Investigator:	Chadwick D Miller, MD	WFUBMC

More Information

Additional Information:

Wake Forest University Baptist Medical Center This link exits the ClinicalTrials.gov site

Publications:

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Miller CD, Hwang W, Case D, Hoekstra JW, Lefebvre C, Blumstein H, Hamilton CA, Harper EN, Hundley WG. Stress CMR imaging observation unit in the emergency department reduces 1-year medical care costs in patients with acute chest pain: a randomized study for comparison with inpatient care. JACC Cardiovasc Imaging. 2011 Aug;4(8):862-70. doi: 10.1016/j.jcmg.2011.04.016.


Responsible Party:	Chadwick Miller, Principal Investigator, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:	NCT00678639 History of Changes
Other Study ID Numbers:	00004120
Study First Received:	May 8, 2008
Results First Received:	March 19, 2010
Last Updated:	February 10, 2017

Keywords provided by Chadwick Miller, Wake Forest University Health Sciences:


ACS Acute Coronary Syndrome Chest pain Cardiac MRI	CMR Risk Stratification Emergency Department

Additional relevant MeSH terms:


Acute Coronary Syndrome Chest Pain Myocardial Ischemia Heart Diseases Cardiovascular Diseases	Vascular Diseases Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on September 25, 2017

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