Randomized Investigation of Chest Pain Diagnostic Strategies
Summary
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 primary objective of this trial is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to inpatient care among patients with non-low risk acute chest pain.
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. 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 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 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 Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Conditions
Acute Coronary Syndrome
Intervention
Clinical decision unit care, coupled with cardiac MRI
Location
Wake Forest University Baptist Medical Center
Winston-Salem
North Carolina
United States
27157
Status
Recruiting
Source
Wake Forest University Baptist Medical Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01035047
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:17:11-0400
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Medical and Biotech [MESH] Definitions
Coronary Care Units
The hospital unit in which patients with acute cardiac disorders receive intensive care.
Decision Support Systems, Clinical
Computer-based information systems used to integrate clinical and patient information and provide support for decision-making in patient care.
Decision Trees
A graphic device used in decision analysis, series of decision options are represented as branches (hierarchical).
Alert Fatigue, Health Personnel
Mental fatigue experienced by health care providers who encounter numerous alerts and reminders from the use of CLINICAL DECISION SUPPORT SYSTEMS. As the numbers of alerts and reminders designed to provide meaningful assistance to the patient care process increases, many health personnel may ignore them.
Decision Support Techniques
Mathematical or statistical procedures used as aids in making a decision. They are frequently used in medical decision-making.
