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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Simon Mahler, MD, Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT01665521
First received: August 7, 2012
Last updated: May 29, 2014
Last verified: May 2014
  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 Phase
Acute Coronary Syndrome
Chest Pain
Other: HEART Pathway
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Objective cardiac testing (stress testing or cardiac imaging) within 30 days [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Index objective cardiac testing rate [ Time Frame: Duration of Index Hospitalization, average of 1 to 2 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Major adverse cardiac events (MACE) [ Time Frame: 30 Days and 1 Year ] [ Designated as safety issue: Yes ]
  • Missed MACE [ Time Frame: 30 Days and 1 Year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Inter-rater reliability of the HEART Pathway [ Time Frame: Duration of the Index ED visit, less than 1 day ] [ Designated as safety issue: No ]

Enrollment: 282
Study Start Date: September 2012
Estimated Study Completion Date: March 2015
Primary Completion Date: March 2014 (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
Genders Eligible for Study:   Both
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 Baptist Health
American Heart Association
Investigators
Principal Investigator: Simon A Mahler, MD Wake Forest Baptist Health
  More Information

Additional Information:
Publications:
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15. Erratum in: Circulation. 2011 Feb 15;123(6):e240. Circulation. 2011 Oct 18;124(16):e426.
Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007 Aug 14;50(7):e1-e157. Erratum in: J Am Coll Cardiol. 2008 Mar 4;51(9):974.
Backus BE, Six AJ, Kelder JH, et al. A prospective validation of the heart score for chest pain patients at the ER. Eur Heart J 2011;32:952.
Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation. 2007 Aug 14;116(7):e148-304. Epub 2007 Aug 6. No abstract available. Erratum in: Circulation. 2008 Mar 4;117(9):e180.
Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction, Jaffe AS, Apple FS, Galvani M, Katus HA, Newby LK, Ravkilde J, Chaitman B, Clemmensen PM, Dellborg M, Hod H, Porela P, Underwood R, Bax JJ, Beller GA, Bonow R, Van der Wall EE, Bassand JP, Wijns W, Ferguson TB, Steg PG, Uretsky BF, Williams DO, Armstrong PW, Antman EM, Fox KA, Hamm CW, Ohman EM, Simoons ML, Poole-Wilson PA, Gurfinkel EP, Lopez-Sendon JL, Pais P, Mendis S, Zhu JR, Wallentin LC, Fernández-Avilés F, Fox KM, Parkhomenko AN, Priori SG, Tendera M, Voipio-Pulkki LM, Vahanian A, Camm AJ, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Morais J, Brener S, Harrington R, Morrow D, Lim M, Martinez-Rios MA, Steinhubl S, Levine GN, Gibler WB, Goff D, Tubaro M, Dudek D, Al-Attar N. Universal definition of myocardial infarction. Circulation. 2007 Nov 27;116(22):2634-53. Epub 2007 Oct 19.

Responsible Party: Simon Mahler, MD, Assistant Professor, Wake Forest Baptist Health
ClinicalTrials.gov Identifier: NCT01665521     History of Changes
Other Study ID Numbers: 12CRP12000001, IRB00021074
Study First Received: August 7, 2012
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
Acute Coronary Syndrome
Chest pain
Risk Stratification
HEART Pathway
Emergency Department

Additional relevant MeSH terms:
Acute Coronary Syndrome
Chest Pain
Emergencies
Syndrome
Angina Pectoris
Cardiovascular Diseases
Disease
Disease Attributes
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014