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

March 3, 2022 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Wake Forest University Baptist Medical Center - Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: HEART Pathway
During ED evaluation, patients are randomized to HEART Pathway or usual care arms.
No Intervention: Usual Care
Conventional Care cardiac testing. Patients will undergo cardiac testing as determined by their treating physicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective cardiac testing (stress testing or cardiac imaging) within 30 days
Time Frame: 30 Days
Rate of objective cardiac testing within 30 days
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost, length of stay, recurrent ED visits and non-index hospitalization for chest pain.
Time Frame: 30 Days
30 Days
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
1 Year
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
Duration of Index Hospitalization, average of 1 to 2 days
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
Duration of Index Hospitalization, average of 1 to 2 days
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
Duration of Index Hospitalization, average of 1 to 2 days
Composite of 30 day hospital admission and objective cardiac testing
Time Frame: 30 Days
30 Days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events (MACE)
Time Frame: 30 Days and 1 Year
30 Days and 1 Year
Missed MACE
Time Frame: 30 Days and 1 Year
MACE occurring in patients discharged without objective cardiac testing.
30 Days and 1 Year
Provider adherence to the HEART Pathway
Time Frame: Duration of Index Hospitalization, average of 1 to 2 days
Duration of Index Hospitalization, average of 1 to 2 days
Inter-rater reliability of the HEART Pathway
Time Frame: Duration of the Index ED visit, less than 1 day
Duration of the Index ED visit, less than 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Simon A Mahler, MD, Wake Forest Baptist Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

February 20, 2016

Study Completion (Actual)

January 15, 2018

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (Estimate)

August 15, 2012

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00021074
  • 12CRP12000001 (Other Identifier: American Heart Association)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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