Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain
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|ClinicalTrials.gov Identifier: NCT00869245|
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : November 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Chest Pain||Other: OU - Cardiac MRI Other: OU - Conventional Care Testing||Not Applicable|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||October 2011|
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.
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.
- Therapeutic efficacy: Length of stay [ Time Frame: Duration of Initial Hospitalization ]
- Therapeutic efficacy: Correct cardiovascular admission decision [ Time Frame: Duration of Initial Hospitalization ]
- Therapeutic efficacy: Non-therapeutic cardiac catheterizations [ Time Frame: 30 days ]
- Diagnostic thinking efficacy: change in diagnostic certainty [ Time Frame: 30 days ]
- Cost of index hospitalization [ Time Frame: Duration of Initial Hospitalization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869245
|United States, North Carolina|
|Wake Forest University Baptist Medical Center - Emergency Department|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Chadwick Miller, M.D.||WFUBMC|