PARA-HEART Pilot Implementation

NCT02709135 | Completed

• 1 other identifier: IRB00036229
• Study Type: observational
• Target: 511
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. These patients are a challenge to healthcare providers, who are tasked with determining whether these symptoms are due to an acute coronary syndrome (ACS) or a non-ACS cause.In an effort to improve the quality and value of care for patients with acute chest pain, our group recently validated a risk stratification pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on higher-risk patients, who are more likely to benefit from testing.While the HEART score has been well validated in the ED setting, it has yet to be implemented in a prehospital setting. Paramedics are often the first providers to evaluate and begin treating patients with symptoms concerning for ACS. Current pre-hospital risk stratification is largely based on a combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI (ST-segment elevation myocardial infarction) are poor predictors of ACS, paramedics often have difficulty distinguishing high-risk patients from low-risk patients.Thus, multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT® point-of-care (POC) troponin testing in the prehospital setting is needed. To establish the feasibility and accuracy of HEART score and POC testing in the prehospital setting the investigators propose a quality surveillance study of a limited implementation of the HEART score with POC troponin testing.

Conditions

Acute Coronary Syndrome; Chest Pain

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Events (MACE) at 30 days

  The primary outcome is MACE at 30 days. MACE is a composite outcome of cardiac death, acute myocardial infarction, and coronary revascularization.

  30 Days

Secondary Outcomes (4)

• Rate of objective cardiac testing

  30 Days

• Length of Stay

  30 Days

• Rate of hospitalization at index

  30 Days

• Rate of cardiac related hospital admissions and ED visits during follow-up

  30 Days

Study Arms (1)

Pre-hospital HEART Score

All subjects included in this quality surveillance study will have had a HEART score, including POC troponin calculated by paramedics prior to arrival at the emergency department.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with symptoms concerning for acute coronary syndrome who are being transported to the Wake Forest Baptist Medical Center Emergency Department by paramedics trained to complete a HEART Score and POC troponin assessment will be eligible for inclusion in this quality surveillance study.

You may qualify if:

• age greater than or equal to 21 years
• Non-traumatic chest discomfort or other symptoms consistent with possible
• Patient being transported to Wake Forest Baptist Health ED for further care

You may not qualify if:

• ST-segment elevation in contiguous leads on any electrocardiogram
• Inter-facility transfers
• Short Pre-hospital times: anticipated scene + transportation time less than 5 mins
• Unstable vitals signs
• Known terminal diagnosis with life expectancy less than 1 year
• Concomitant non-cardiac medical, surgical, or psychiatric emergency

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School Of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (26)

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• Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. No abstract available.

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• Stopyra JP, Snavely AC, Smith LM, Harris RD, Nelson RD, Winslow JE, Alson RL, Pomper GJ, Riley RF, Ashburn NP, Hendley NW, Gaddy J, Woodrum T, Fornage L, Conner D, Alvarez M, Pflum A, Koehler LE, Miller CD, Mahler SA. Prehospital use of a modified HEART Pathway and point-of-care troponin to predict cardiovascular events. PLoS One. 2020 Oct 7;15(10):e0239460. doi: 10.1371/journal.pone.0239460. eCollection 2020.

  PMID: 33027260 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Mahler, MD, MS

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 15, 2016
• Study Start: December 1, 2016
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: March 4, 2022

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)