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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00869245

Collaborator

American Heart Association (Other)

124

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Chest Pain	Other: OU - Cardiac MRI Other: OU - Conventional Care Testing	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.	Other: OU - Cardiac MRI During ED evaluation, patients are randomized to cardiac MRI or conventional care testing.
Experimental: 2 Conventional care cardiac testing. Patients will be transferred to the observation unit and undergo cardiac testing as determined by their treating physician.	Other: OU - Conventional Care Testing Patients in the conventional testing arm will undergo testing as determined by their treating physician.

Arm

Intervention/Treatment

Experimental: 1

Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.

Other: OU - Cardiac MRI

During ED evaluation, patients are randomized to cardiac MRI or conventional care testing.

Experimental: 2

Conventional care cardiac testing. Patients will be transferred to the observation unit and undergo cardiac testing as determined by their treating physician.

Other: OU - Conventional Care Testing

Patients in the conventional testing arm will undergo testing as determined by their treating physician.

Outcome Measures

Primary Outcome Measures

Therapeutic efficacy: Length of stay [Duration of Initial Hospitalization]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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**