This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
May 8, 2008
February 10, 2017
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 ]
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 ]
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 ]
    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 ]
    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 ]
    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. ]
    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 ]
  • 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 ]
  • Health care utilization, measured as self report, assessed during telephone follow up. [ Time Frame: 30d, 3mo, 6mo, and 1 year ]
  • General state of health, assessed via telephone follow-up [ Time Frame: 30d, 3mo, 6mo, and 1 year ]
  • Adverse events during MRI scanning [ Time Frame: Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition. ]
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
Intervention Model: Parallel Assignment
Masking: 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00678639
00004120
No
Not Provided
Not Provided
Chadwick Miller, Wake Forest University Health Sciences
Chadwick Miller
Not Provided
Principal Investigator: Chadwick D Miller, MD WFUBMC
Wake Forest University Health Sciences
February 2017

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