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
Results First Received: March 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions: Acute Coronary Syndrome
Chest Pain
Intervention: Other: Observation unit care, coupled with cardiac MRI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the emergency department January 2008 - March 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Once consented, no participants were excluded from the trial prior to group assignment.

Reporting Groups
  Description
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.
Usual Care This is the comparison arm. Patients are admitted to the hospital and undergo usual care.

Participant Flow:   Overall Study
    Emergency Department (ED) Observation Unit     Usual Care  
STARTED     53     57  
Hospital Discharge     53     57  
COMPLETED     51     57  
NOT COMPLETED     2     0  
Lost to Follow-up at 30 days                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
Usual Care This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Total Total of all reporting groups

Baseline Measures
    Emergency Department (ED) Observation Unit     Usual Care     Total  
Number of Participants  
[units: participants]
  53     57     110  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     45     47     92  
>=65 years     8     10     18  
Gender  
[units: participants]
     
Female     28     27     55  
Male     25     30     55  
Region of Enrollment  
[units: participants]
     
United States     53     57     110  



  Outcome Measures
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1.  Primary:   Cost of Index Hospitalization   [ Time Frame: Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours ]

2.  Secondary:   Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days   [ Time Frame: 30 Days ]

3.  Secondary:   The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging   [ Time Frame: Emergency Department (ED) arrival through hospital discharge ]

4.  Secondary:   Number of Participants Who Utilized the Indicated Health Care Procedures   [ Time Frame: 30d, 3mo, 6mo, and 1 year ]

5.  Secondary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Chadwick Miller, MD
Organization: Wake Forest University Baptist Medical Center
phone: 336-716-1740
e-mail: cmiller@wfubmc.edu


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.
Klocke FJ, Baird MG, Lorell BH, Bateman TM, Messer JV, Berman DS, O'Gara PT, Carabello BA, Russell RO Jr, Cerqueira MD, St John Sutton MG, DeMaria AN, Udelson JE, Kennedy JW, Verani MS, Williams KA, Antman EM, Smith SC Jr, Alpert JS, Gregoratos G, Anderson JL, Hiratzka LF, Faxon DP, Hunt SA, Fuster V, Jacobs AK, Gibbons RJ, Russell RO; American College of Cardiology; American Heart Association; American Society for Nuclear Cardiology. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 1995 Guidelines for the Clinical Use of Cardiac Radionuclide Imaging). J Am Coll Cardiol. 2003 Oct 1;42(7):1318-33. No abstract available.
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:

Responsible Party: Chadwick Miller, MD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00678639     History of Changes
Other Study ID Numbers: 00004120
Study First Received: May 8, 2008
Results First Received: March 19, 2010
Last Updated: April 28, 2010
Health Authority: United States: Institutional Review Board