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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:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00678639
First received: May 8, 2008
Last updated: April 28, 2010
Last verified: April 2010

May 8, 2008
April 28, 2010
January 2008
March 2009   (final data collection date for primary outcome measure)
Cost of Index Hospitalization [ Time Frame: Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours ] [ Designated as safety issue: No ]
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.
Cost of Index Hospitalization [ Time Frame: Index hospitalization ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00678639 on ClinicalTrials.gov Archive Site
  • Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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.
  • Correct Admission Decision, based upon the reference standard of acute coronary syndrome (ACS) at 30 days. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Success of CMR Imaging. The proportion of subjects randomized to the OU and able to complete the CMR imaging protocol will be determined. [ Time Frame: Index hospitalization ] [ Designated as safety issue: No ]
  • Health care utilization, measured as self report, assessed during telephone follow up. [ Time Frame: 30d, 3mo, 6mo, and 1 year ] [ Designated as safety issue: No ]
  • General state of health, assessed via telephone follow-up [ Time Frame: 30d, 3mo, 6mo, and 1 year ] [ Designated as safety issue: No ]
  • Adverse events during MRI scanning [ Time Frame: Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain
Randomized Cost Comparison of Cardiac MRI Use in ED Patients With Chest Pain

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Acute Coronary Syndrome
  • Chest Pain
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.
  • 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.
    Intervention: Other: Observation unit care, coupled with cardiac MRI
  • No Intervention: Usual care
    This is the comparison arm. Patients are admitted to the hospital and undergo usual care.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
Not Provided
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00678639
00004120
No
Chadwick Miller, MD, Wake Forest University Health Sciences
Wake Forest Baptist Health
Not Provided
Principal Investigator: Chadwick D Miller, MD WFUBMC
Wake Forest Baptist Health
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP