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

Acute Coronary Syndrome Clinical Trial

Official title:

Randomized Cost Comparison of Cardiac MRI Use in ED Patients With Chest Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678639
• Other study ID #: IRB00004120
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest University Baptist Medical Center - Emergency Department	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost of Index Hospitalization	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.	Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours
Secondary	Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 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.	30 Days
Secondary	The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging	The number of participants able to complete the planned imaging sequences will be measured.	Emergency Department (ED) arrival through hospital discharge
Secondary	Number of Participants Who Utilized the Indicated Health Care Procedures	Measured as self report, assessed during telephone follow-up.	30d, 3mo, 6mo, and 1 year
Secondary	Adverse Events During Magnetic Resonance Imaging (MRI) Scanning	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.	Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.

External Links

•   Wake Forest University Baptist Medical Center