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Winston-Salem, North Carolina 27157


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.


Study summary:

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.


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


NCT ID:

NCT00678639


Primary Contact:

Principal Investigator
Chadwick D Miller, MD
WFUBMC


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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