Randomized Investigation of Chest Pain Diagnostic Strategies
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|ClinicalTrials.gov Identifier: NCT01035047|
Recruitment Status : Completed
First Posted : December 18, 2009
Results First Posted : November 29, 2012
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Chest Pain||Other: Clinical decision unit care, coupled with cardiac MRI||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. Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses 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 and invasive procedures. The high sensitivity for ongoing ischemia could allow imaging in parallel with cardiac markers. As a result, CMR could improve the care of emergency department (ED) patients with intermediate risk chest pain. However, the efficiency and safety of CMR has not been extensively tested in the CDU setting.
Primary Hypothesis: A CDU-CMR strategy will reduce the occurrence of the composite of revascularization, re-hospitalization, and recurrent cardiac testing at 90 days when compared to an inpatient care strategy.
Methods: Participants (n=146) at intermediate risk for acute coronary syndrome (ACS) will be recruited into a clinical trial from Wake Forest University Baptist Medical Center (WFUBMC) ED. Participants will be equally randomized to CDU-CMR or inpatient care. CDU-CMR participants will undergo resting and stress CMR imaging in parallel with serial cardiac markers. Inpatient care participants will undergo serial cardiac markers followed by existing cardiac testing as determined by their care providers. The primary outcome is the composite of 90 day revascularization, re-hospitalization, and recurrent cardiac testing. The secondary outcome is index hospitalization length of stay. Safety events include ACS after discharge, mortality, and stress testing-related adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Investigation of Chest Pain Diagnostic Strategies|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||August 2012|
No Intervention: Inpatient Care
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Experimental: CDU-CMR Protocol
Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Other: Clinical decision unit care, coupled with cardiac MRI
After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
- The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. [ Time Frame: Index Hospitalization through 90 days ]
- Length of Stay [ Time Frame: Duration of Index Hospitalization, an average of 1-2 days ]
- Acute Coronary Syndrome [ Time Frame: Index Hospitalization discharge through 90 days ]
- Mortality [ Time Frame: Index Hospitalization through 90 days ]
- Stress Testing-related Adverse Event [ Time Frame: Index Hospitalization through 90 days ]
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): NCT01035047
|United States, North Carolina|
|Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Chadwick Miller, M.D.||WFUBMC|