Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain
NCT ID: NCT01665521
Last Updated: 2022-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
282 participants
INTERVENTIONAL
2012-09-30
2018-01-15
Brief Summary
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Detailed Description
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Implementation of accurate risk stratification care pathways designed to eliminate unnecessary cardiac testing could improve the efficiency and quality of care by decreasing false positive/non-diagnostic testing, radiation, and costs. The HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, is a recently developed care pathway designed to identify chest pain patients for early discharge without objective testing.
Primary Hypothesis: The HEART Pathway, when compared to usual care, will reduce 30 day objective cardiac testing, hospital length of stay, and cost, while maintaining patient safety.
Methods: Participants (n=282) at risk for ACS will be recruited into a clinical trial from Wake Forest Baptist Medical Center (WFBMC) ED. Patients will be equally randomized to HEART Pathway or Usual Care. HEART Pathway participant's treating physician will follow HEART Pathway guidelines for identifying patients to be admitted to the hospital or observation unit for cardiac testing or to be discharged home without testing. Usual Care participant's treating physicians will decide whether the patients should be discharged home or admitted to the hospital or observation unit based on ACC/AHA guidelines without using the HEART pathway.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HEART Pathway
The HEART Pathway will be used for real time clinical decision making. Physicians will receive care recommendations according to the HEART Pathway, based on HEART score and serial cardiac biomarkers. This will help physicians identify low-risk patients for early discharge with no objective cardiac testing.
HEART Pathway
During ED evaluation, patients are randomized to HEART Pathway or usual care arms.
Usual Care
Conventional Care cardiac testing. Patients will undergo cardiac testing as determined by their treating physicians.
No interventions assigned to this group
Interventions
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HEART Pathway
During ED evaluation, patients are randomized to HEART Pathway or usual care arms.
Eligibility Criteria
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Inclusion Criteria
* Chest discomfort or other symptoms consistent with possible ACS
* The treating physician feels the patient could be discharged home if cardiac disease was excluded
* ED attending physicians
Exclusion Criteria
* Unstable vitals signs: symptomatic hypotension at the time of enrollment (systolic \< 90 mm Hg), tachycardia (HR\>120), bradycardia (HR\<40), and hypoxemia (\<90% pulse-oximetry on room air or normal home oxygen flow rate)
* Terminal diagnosis with life expectancy less than 1 year
* A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission, increase risk of objective cardiac testing, or prevent immediate discharge following negative testing.
* Prior enrollment
* Incapacity or unwillingness to provide consent and comply with study procedures
* Non-English speaking
Sub-study I \& II
* ED attending physicians who decline to participate
21 Years
ALL
No
Sponsors
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American Heart Association
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Simon A Mahler, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest Wake Forest University Baptist Medical Center - Emergency Department
Winston-Salem, North Carolina, United States
Countries
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References
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Related Links
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Wake Forest Baptist Health
Other Identifiers
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12CRP12000001
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00021074
Identifier Type: -
Identifier Source: org_study_id
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