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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

American Heart Association

Information provided by (Responsible Party):

Simon Mahler, MD, Wake Forest University Health Sciences

ClinicalTrials.gov Identifier:

NCT01665521

First received: August 7, 2012

Last updated: June 13, 2017

Last verified: June 2017

History of Changes

Purpose

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.

Condition	Intervention
Acute Coronary Syndrome Chest Pain	Other: HEART Pathway


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment
Official Title:	Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain

U.S. FDA Resources

Further study details as provided by Simon Mahler, MD, Wake Forest University Health Sciences:

Primary Outcome Measures:

Objective cardiac testing (stress testing or cardiac imaging) within 30 days [ Time Frame: 30 Days ]
Rate of objective cardiac testing within 30 days

Secondary Outcome Measures:

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 ]
proportion of patients receiving any stress testing modality, coronary computed tomography angiography, or invasive catheter angiography at the index visit
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
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
Composite of 30 day hospital admission and objective cardiac testing [ Time Frame: 30 Days ]

Other Outcome Measures:

Major adverse cardiac events (MACE) [ Time Frame: 30 Days and 1 Year ]
Missed MACE [ Time Frame: 30 Days and 1 Year ]
MACE occurring in patients discharged without objective cardiac testing.
Provider adherence to the HEART Pathway [ Time Frame: 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 ]


Enrollment:	282
Study Start Date:	September 2012
Estimated Study Completion Date:	August 2017
Primary Completion Date:	February 20, 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665521

Locations


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

Sponsors and Collaborators

Wake Forest University Health Sciences

American Heart Association

Investigators


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

More Information

Additional Information:

Wake Forest Baptist Health This link exits the ClinicalTrials.gov site

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mahler SA, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD. The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):195-203. doi: 10.1161/CIRCOUTCOMES.114.001384. Epub 2015 Mar 3.


Responsible Party:	Simon Mahler, MD, Associate Professor, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:	NCT01665521 History of Changes
Other Study ID Numbers:	12CRP12000001 IRB00021074 ( Other Identifier: Wake Forest School of Medicine )
Study First Received:	August 7, 2012
Last Updated:	June 13, 2017

Keywords provided by Simon Mahler, MD, Wake Forest University Health Sciences:


Acute Coronary Syndrome Chest pain Risk Stratification HEART Pathway Emergency Department

Additional relevant MeSH terms:


Emergencies Acute Coronary Syndrome Chest Pain Disease Attributes Pathologic Processes Myocardial Ischemia Heart Diseases	Cardiovascular Diseases Vascular Diseases Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on July 27, 2017

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