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Completed

NCT Number: NCT01665521

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Wake Forest University Baptist Medical Center - Emergency Department

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • ED attending physicians who decline to participate

Treatment and study plan

HEART Pathway

Other

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

Primary outcomes

  1. Objective cardiac testing (stress testing or cardiac imaging) within 30 days

    Time frame: 30 Days

    Rate of objective cardiac testing within 30 days

Secondary outcomes

  1. Cost, length of stay, recurrent ED visits and non-index hospitalization for chest pain.

    Time frame: 30 Days

  2. Objective cardiac testing (stress testing or cardiac imaging), cost, length of stay, and recurrent ED visits and non-index hospitalization for chest pain.

    Time frame: 1 Year

  3. Index objective cardiac testing rate

    Time frame: Duration of Index Hospitalization, average of 1 to 2 days

    proportion of patients receiving any stress testing modality, coronary computed tomography angiography, or invasive catheter angiography at the index visit

  4. Index Hospital Admission Rate

    Time frame: Duration of Index Hospitalization, average of 1 to 2 days

    Proportion of patients hospitalized for admission or observation during the index visit

  5. Early discharge rate

    Time frame: Duration of Index Hospitalization, average of 1 to 2 days

    Proportion of patients that are discharged from the Emergency Department without meeting the composite endpoint of index hospital admission or index objective cardiac testing

  6. Composite of 30 day hospital admission and objective cardiac testing

    Time frame: 30 Days

Other outcomes

  1. Major adverse cardiac events (MACE)

    Time frame: 30 Days and 1 Year

  2. Missed MACE

    Time frame: 30 Days and 1 Year

    MACE occurring in patients discharged without objective cardiac testing.

  3. Provider adherence to the HEART Pathway

    Time frame: Duration of Index Hospitalization, average of 1 to 2 days

  4. Inter-rater reliability of the HEART Pathway

    Time frame: Duration of the Index ED visit, less than 1 day

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • American Heart Association

Registry information

Acronym: HEART Pathway

Important dates

Study start
2012
Primary completion
2016
Study completion
2018
First posted
Aug 15, 2012
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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