Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome; Chest Pain
• Interventions: Other: OU - Cardiac MRI; Other: OU - Conventional Care Testing

• Registration Number: NCT00869245
• Lead Sponsor: Wake Forest University Health Sciences

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 observation unit. Patients will either undergo cardiac MRI testing or conventional care testing. Patients treated in the conventional care testing group 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.

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) improve resource utilization, are endorsed by the ACC/AHA guidelines, but have seen limited implementation in non-low risk chest pain patients due to limitations of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The superior accuracy of CMR could decrease testing resulting from false positive results. The high sensitivity for ongoing ischemia could allow imaging in parallel with cardiac markers.

Research hypotheses:

OU-CMR will have superior therapeutic efficacy to OU-conventional testing.

An OU-CMR strategy will have higher diagnostic thinking efficacy than OU-conventional testing.

Methods summary:

To address the question of feasibility of a CMR approach to managing patients at intermediate risk for ACS, we propose a randomized clinical trial of 120 patients at intermediate risk of ACS that present to the ED of Wake Forest University Baptist Medical Center (WFUBMC) for evaluation of chest pain. All patients will receive care in an OU, and will be randomized to CMR, or conventional testing. CMR participants will undergo cardiac markers and CMR testing; conventional testing participants will undergo serial cardiac markers followed by conventional 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Primary Completion: 2010-09
• Study Completion: 2011-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• 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 Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	OU - Cardiac MRI	Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
2	OU - Conventional Care Testing	Conventional care cardiac testing. Patients will be transferred to the observation unit and undergo cardiac testing as determined by their treating physician.

Primary Outcome Measures

Name	Time	Method
Therapeutic efficacy: Length of stay	Duration of Initial Hospitalization

Secondary Outcome Measures

Name	Time	Method
Therapeutic efficacy: Correct cardiovascular admission decision	Duration of Initial Hospitalization
Diagnostic thinking efficacy: change in diagnostic certainty	30 days
Therapeutic efficacy: Non-therapeutic cardiac catheterizations	30 days
Cost of index hospitalization	Duration of Initial Hospitalization

Trial Locations

Locations (1)

Wake Forest University Baptist Medical Center - Emergency Department; 🇺🇸 Winston-Salem, North Carolina, United States