Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain

NCT00678639 | Completed Results FDA Device

• 1 other identifier: IRB00004120
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Chest Pain

Keywords

ACS; Acute Coronary Syndrome; Chest pain; Cardiac MRI; CMR; Risk Stratification; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Cost of Index Hospitalization

  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.

  Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours

Secondary Outcomes (4)

• Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days

  30 Days

• The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging

  Emergency Department (ED) arrival through hospital discharge

• Number of Participants Who Utilized the Indicated Health Care Procedures

  30d, 3mo, 6mo, and 1 year

• Adverse Events During Magnetic Resonance Imaging (MRI) Scanning

  Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.

Study Arms (2)

Emergency Department (ED) Observation unit

EXPERIMENTAL

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

Usual care

NO INTERVENTION

This is the comparison arm. Patients are admitted to the hospital and undergo usual care.

Interventions

Observation unit care, coupled with cardiac MRI OTHER

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.

Emergency Department (ED) Observation unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Renal insufficiency(done prior to enrollment)or end stage renal disease
• Chronic liver disease (ex. hepatitis, cirrhosis)
• History of liver, heart, or kidney transplant

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Baptist Medical Center - Emergency Department

Winston-Salem, North Carolina, 27157, United States

Location

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MeSH Terms

Conditions

Acute Coronary Syndrome; Chest Pain; Emergencies

Interventions

Family Characteristics

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Socioeconomic Factors; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Chadwick Miller, MD
• Organization: Wake Forest University Baptist Medical Center

cmiller@wfubmc.edu

336-716-1740

Study Officials

• Chadwick D Miller, MD

  WFUBMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 15, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 11, 2018
• Results First Posted: April 28, 2010

Record last verified: 2018-08

Locations

US (1)