Overview

This trial is active, not recruiting.

Conditions acute coronary syndrome, chest pain
Treatment heart pathway
Phase phase 3
Sponsor Wake Forest Baptist Health
Collaborator American Heart Association
Start date September 2012
End date March 2014
Trial size 282 participants
Trial identifier NCT01665521, 12CRP12000001, IRB00021074

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
(No Intervention)
Conventional Care cardiac testing. Patients will undergo cardiac testing as determined by their treating physicians.

Primary Outcomes

Measure
Objective cardiac testing (stress testing or cardiac imaging) within 30 days
time frame: 30 Days

Secondary Outcomes

Measure
Cost, length of stay, recurrent ED visits and non-index hospitalization for chest pain.
time frame: 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
Index objective cardiac testing rate
time frame: 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
Early discharge rate
time frame: Duration of Index Hospitalization, average of 1 to 2 days
Composite of 30 day hospital admission and objective cardiac testing
time frame: 30 Days

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain
Principal investigator Simon A Mahler, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Wake Forest Baptist Health.