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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
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Chest Pain Other: Observation unit care, coupled with cardiac MRI Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

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


Locations
United States, North Carolina
Wake Forest University Baptist Medical Center - Emergency Department
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Chadwick D Miller, MD WFUBMC
More Information
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Additional Information:
Wake Forest University Baptist Medical Center  This link exits the ClinicalTrials.gov site

Publications:
Committee on the Future of Emergency Care in the United States Health System. 2006. Hospital-Based Emergency Care: At the Breaking Point. Washington, DC: The National Academies Press.
Miller CD, Lindsell CJ, Fermann GJ, et al. After the First Negative Troponin: Distinguishing Patients with Evolving Myocardial Infarctions from Those Without Infarction in Emergency Department Patients with Chest Pain. Annals of Emergency Medicine 2005;46(3, Supplement 1):114-5.

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

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00678639     History of Changes
Other Study ID Numbers: IRB00004120
First Posted: May 15, 2008    Key Record Dates
Results First Posted: April 28, 2010
Last Update Posted: September 11, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by 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