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Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain

Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01665521
Acronym
HEART Pathway
Enrollment
282
Registered
2012-08-15
Start date
2012-09-30
Completion date
2018-01-15
Last updated
2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Chest Pain

Keywords

Acute Coronary Syndrome, Chest pain, Risk Stratification, HEART Pathway, Emergency Department

Brief summary

Our research will examine a chest pain care strategy, called the HEART pathway, which is designed to correctly identify Emergency Department patients at high-risk for cardiovascular events, likely to benefit from further testing, and patients at very-low-risk for cardiovascular events, who may be safely discharged home. By using an individual's risk assessment to determining testing, we hope to improve the quality and efficiency of the care delivered to Emergency Department patients with chest pain. Our study will determine if the HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, will reduce stress testing and cardiovascular imaging, decrease hospital length of stay, and reduce cost compared to usual care, while maintaining safety.

Detailed description

Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. The total cost of chest pain evaluations has been estimated at $5-10 billion annually, yet only 10% of these patients are ultimately diagnosed with an acute coronary syndrome. American College of Cardiology/ American Heart Association (ACC/AHA) guidelines recommend that patients at low-risk for acute coronary syndrome should receive serial cardiac markers followed by objective cardiac testing (stress testing or cardiac imaging). However, many have questioned the value of objective cardiac testing in all low-risk patients.Cardiac testing for all patients at low-risk for acute coronary syndrome (ACS) is not sustainable from a healthcare quality or economic perspective. In addition to increasing costs, objective cardiac testing is associated with a substantial number of false positive and non-diagnostic tests, which lead to additional unnecessary and often invasive procedures. 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.

Interventions

OTHERHEART Pathway

During ED evaluation, patients are randomized to HEART Pathway or usual care arms.

Sponsors

American Heart Association
CollaboratorOTHER
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age greater than or equal to 21 years * Chest discomfort or other symptoms consistent with possible ACS * The treating physician feels the patient could be discharged home if cardiac disease was excluded

Exclusion criteria

* New ST-segment elevation in contiguous leads on any electrocardiogram (\>/= 1 mV) * 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 Inclusion Criteria: * ED attending physicians

Design outcomes

Primary

MeasureTime frameDescription
Objective cardiac testing (stress testing or cardiac imaging) within 30 days30 DaysRate of objective cardiac testing within 30 days

Secondary

MeasureTime frameDescription
Objective cardiac testing (stress testing or cardiac imaging), cost, length of stay, and recurrent ED visits and non-index hospitalization for chest pain.1 Year
Index objective cardiac testing rateDuration of Index Hospitalization, average of 1 to 2 daysproportion of patients receiving any stress testing modality, coronary computed tomography angiography, or invasive catheter angiography at the index visit
Index Hospital Admission RateDuration of Index Hospitalization, average of 1 to 2 daysProportion of patients hospitalized for admission or observation during the index visit
Early discharge rateDuration of Index Hospitalization, average of 1 to 2 daysProportion of patients that are discharged from the Emergency Department without meeting the composite endpoint of index hospital admission or index objective cardiac testing
Composite of 30 day hospital admission and objective cardiac testing30 Days
Cost, length of stay, recurrent ED visits and non-index hospitalization for chest pain.30 Days

Other

MeasureTime frameDescription
Provider adherence to the HEART PathwayDuration of Index Hospitalization, average of 1 to 2 days
Inter-rater reliability of the HEART PathwayDuration of the Index ED visit, less than 1 day
Missed MACE30 Days and 1 YearMACE occurring in patients discharged without objective cardiac testing.
Major adverse cardiac events (MACE)30 Days and 1 Year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026