Clinical trial NCT00678639: Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain
Official title: Randomized Cost Comparison of Cardiac MRI Use in ED Patients With Chest Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Chest Pain
Keywords: ACS
Acute Coronary Syndrome
Chest pain
Cardiac MRI
CMR
Risk Stratification
Emergency Department
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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:

1. Patients in an OU CMR protocol will have lower cost for the index hospitalization than standard care.
2. 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 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

Primary outcomes:
measure: Cost of Index Hospitalization
timeFrame: Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours
Secondary outcomes:
measure: Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days
timeFrame: 30 Days
measure: The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging
timeFrame: Emergency Department (ED) arrival through hospital discharge
measure: Number of Participants Who Utilized the Indicated Health Care Procedures
timeFrame: 30d, 3mo, 6mo, and 1 year
measure: Adverse Events During Magnetic Resonance Imaging (MRI) Scanning
timeFrame: Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center - Emergency Department
state: North Carolina
Study officials:
affiliation: WFUBMC
name: Chadwick D Miller, MD
role: PRINCIPAL_INVESTIGATOR
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