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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 (Responsible Party):
Chadwick Miller, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00678639
First received: May 8, 2008
Last updated: February 10, 2017
Last verified: February 2017
Results First Received: March 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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.
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 53   57   110 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      45  84.9%      47  82.5%      92  83.6% 
>=65 years      8  15.1%      10  17.5%      18  16.4% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      28  52.8%      27  47.4%      55  50.0% 
Male      25  47.2%      30  52.6%      55  50.0% 
Region of Enrollment 
[Units: Participants]
     
United States   53   57   110 


  Outcome Measures
  Show All Outcome Measures

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.
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: Chadwick Miller, 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: February 10, 2017