N/A
N=110
Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain
Acute Coronary Syndrome · Chest Pain
Bottom Line
View on ClinicalTrials.gov: NCT00678639 ↗Enrolled (actual)
110
Serious AEs
8.2%
Results posted
Apr 2010
Primary outcome: Primary: Cost of Index Hospitalization — 2062; 2680 US Dollars
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Observation unit care, coupled with cardiac MRI (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cost of Index Hospitalization |
2062; 2680 | — |
| SECONDARY Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days |
43; 6 | <0.001 sig |
| SECONDARY The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging |
46 | — |
| SECONDARY Number of Participants Who Utilized the Indicated Health Care Procedures |
7; 4; 0; 4; 0; 3 | — |
| SECONDARY Adverse Events During Magnetic Resonance Imaging (MRI) Scanning |
3; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00678639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.