Status:
COMPLETED
Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
American Heart Association
Conditions:
Acute Coronary Syndrome
Chest Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 types of cardiac tests performed while receiving treatment in an ...
Detailed Description
Despite spending $12 billion annually on the emergency evaluation of chest pain in the US, only 15% of admitted patients have a cardiac cause of their presenting symptoms. Observation units (OU) impro...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years
- Chest discomfort or other symptoms consistent with possible ACS
- TIMI risk score ≥ 1 or physician impression\* of intermediate or high likelihood symptoms represent ACS
- Patient requires an inpatient or observation unit evaluation for their chest pain
- The treating physician feels the patient could be discharged home if cardiac disease was excluded
- ED attending feels patient is safe for observation unit care\*\*
Exclusion
- Initial troponin I \> 1.0 ng/ml
- New ST-segment elevation (≥1mV) or depression (≥2 mV)
- Contra-indications to MRI (listed below)
- Unable to lie flat
- Hypotension (systolic \< 90 mm Hg)
- Renal insufficiency (estimated GFR \< 45 cc/min) or end stage renal disease
- Life expectancy less than 3 months
- Patient refusal of medical record review and follow-up at 30 days
- Pregnancy
- Liver, heart, or kidney transplant
- Chronic liver disease
- Unable to speak English or Spanish
- The ED attending feels that cardiac catheterization is indicated
- The ED care provider intends to order a CT coronary angiogram
- (\*)Physicians are encouraged to use the 2007 ACC/AHA guidelines for the management of patients with NSTE ACS as a framework for this assessment.(1)
- (\*\*)These patients should generally not be considered for observation unit care: PCI / CAGB in past 6 months, multiple stents, multiple prior MIs
- Contraindications to MRI: (Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, claustrophobia)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00869245
Start Date
March 1 2009
End Date
October 1 2011
Last Update
November 8 2017
Active Locations (1)
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1
Wake Forest University Baptist Medical Center - Emergency Department
Winston-Salem, North Carolina, United States, 27157