Prehospital Translation of Chest Pain Tools

NCT03494556 | Completed

• 1 other identifier: IRB00048904
• Study Type: observational
• Target: 365
• Locations: 1 country
• Sites: 2

Brief Summary

Decision aids such as the HEART Pathway, Emergency Department Assessment of Chest Pain Score (EDACS), Revised Geneva Score and PERC Score have similar ability to accurately risk stratify Emergency Department (ED) patients with possible Acute Coronary Syndrome (ACS) and Pulmonary Embolism (PE) and have become standard practice in the ED setting. This study seeks to determine whether prehospital use of these decision aids is feasible and determine which are the most sensitive and specific for prediction of ACS and PE, respectively.

Conditions

Acute Coronary Syndrome; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Determine whether prehospital chest pain decision aid use is feasible.

  Paramedics and blinded Emergency Department providers will be complete four risk stratification tools on a convenience sample of patients with acute chest pain. Inter-rater reliability (kappa) will be determined for each tool.

  24 hours

Secondary Outcomes (1)

• Compare decision aids to determine which are the most sensitive and specific

  30 days

Study Arms (1)

No Intervention

Paramedic will use data collected during routine care to complete four risk stratification tools.

Other: Data Collection

Interventions

Data Collection OTHER

Paramedic will use data collected during routine care to complete four risk stratification tools.

No Intervention

Eligibility Criteria

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

Study Population

Patients being transported to the Emergency Department by Cumberland or New Hanover County EMS.

You may qualify if:

• Age greater than or equal to 21
• Acute non-traumatic chest pain
• Transported by Cumberland or New Hanover County EMS to a local Emergency Department

You may not qualify if:

• Patients with evidence of ST elevation myocardial infarction (STEMI) on ECG
• Inter-facility transports (transfers)
• Patients with unstable vital signs
• Prisoners
• Non-english speakers

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Cape Fear Valley Mobile Integrated Healthcare Cumberland County EMS: collaborator
• New Hanover Regional Medical Center EMS: collaborator

Study Sites (2)

Cape Fear Valley Mobile Integrated Healthcare Cumberland County EMS

Fayetteville, North Carolina, 28304, United States

Location

New Hanover Regional Medical Center EMS

Wilmington, North Carolina, 28401, United States

Location

Related Publications (16)

• Owens PL, Barrett ML, Gibson TB, Andrews RM, Weinick RM, Mutter RL. Emergency department care in the United States: a profile of national data sources. Ann Emerg Med. 2010 Aug;56(2):150-65. doi: 10.1016/j.annemergmed.2009.11.022. Epub 2010 Jan 15.

  PMID: 20074834 BACKGROUND

• Lowthian JA, Cameron PA, Stoelwinder JU, Curtis A, Currell A, Cooke MW, McNeil JJ. Increasing utilisation of emergency ambulances. Aust Health Rev. 2011 Feb;35(1):63-9. doi: 10.1071/AH09866.

  PMID: 21367333 BACKGROUND

• Pittet V, Burnand B, Yersin B, Carron PN. Trends of pre-hospital emergency medical services activity over 10 years: a population-based registry analysis. BMC Health Serv Res. 2014 Sep 10;14:380. doi: 10.1186/1472-6963-14-380.

  PMID: 25209450 BACKGROUND

• Saddichha S, Saxena MK. Is every chest pain a cardiac event? : an audit of patients with chest pain presenting to emergency services in India. Intern Emerg Med. 2009 Jun;4(3):235-9. doi: 10.1007/s11739-009-0246-3. Epub 2009 Apr 15.

  PMID: 19367468 BACKGROUND

• Burman RA, Zakariassen E, Hunskaar S. Acute chest pain - a prospective population based study of contacts to Norwegian emergency medical communication centres. BMC Emerg Med. 2011 Jul 21;11:9. doi: 10.1186/1471-227X-11-9.

  PMID: 21777448 BACKGROUND

• Mahler SA, Miller CD, Hollander JE, Nagurney JT, Birkhahn R, Singer AJ, Shapiro NI, Glynn T, Nowak R, Safdar B, Peberdy M, Counselman FL, Chandra A, Kosowsky J, Neuenschwander J, Schrock JW, Plantholt S, Diercks DB, Peacock WF. Identifying patients for early discharge: performance of decision rules among patients with acute chest pain. Int J Cardiol. 2013 Sep 30;168(2):795-802. doi: 10.1016/j.ijcard.2012.10.010. Epub 2012 Oct 30.

  PMID: 23117012 BACKGROUND

• 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.

  PMID: 25737484 BACKGROUND

• Thang ND, Sundstrom BW, Karlsson T, Herlitz J, Karlson BW. ECG signs of acute myocardial ischemia in the prehospital setting of a suspected acute coronary syndrome and its association with outcomes. Am J Emerg Med. 2014 Jun;32(6):601-5. doi: 10.1016/j.ajem.2014.03.006. Epub 2014 Mar 15.

  PMID: 24731933 BACKGROUND

• Mahler SA, Hiestand BC, Goff DC Jr, Hoekstra JW, Miller CD. Can the HEART score safely reduce stress testing and cardiac imaging in patients at low risk for major adverse cardiac events? Crit Pathw Cardiol. 2011 Sep;10(3):128-33. doi: 10.1097/HPC.0b013e3182315a85.

  PMID: 21989033 BACKGROUND

• Flaws D, Than M, Scheuermeyer FX, Christenson J, Boychuk B, Greenslade JH, Aldous S, Hammett CJ, Parsonage WA, Deely JM, Pickering JW, Cullen L. External validation of the emergency department assessment of chest pain score accelerated diagnostic pathway (EDACS-ADP). Emerg Med J. 2016 Sep;33(9):618-25. doi: 10.1136/emermed-2015-205028. Epub 2016 Jul 12.

  PMID: 27406833 BACKGROUND

• Than M, Flaws D, Sanders S, Doust J, Glasziou P, Kline J, Aldous S, Troughton R, Reid C, Parsonage WA, Frampton C, Greenslade JH, Deely JM, Hess E, Sadiq AB, Singleton R, Shopland R, Vercoe L, Woolhouse-Williams M, Ardagh M, Bossuyt P, Bannister L, Cullen L. Development and validation of the Emergency Department Assessment of Chest pain Score and 2 h accelerated diagnostic protocol. Emerg Med Australas. 2014 Feb;26(1):34-44. doi: 10.1111/1742-6723.12164. Epub 2014 Jan 15.

  PMID: 24428678 BACKGROUND

• Le Gal G, Righini M, Roy PM, Sanchez O, Aujesky D, Bounameaux H, Perrier A. Prediction of pulmonary embolism in the emergency department: the revised Geneva score. Ann Intern Med. 2006 Feb 7;144(3):165-71. doi: 10.7326/0003-4819-144-3-200602070-00004.

  PMID: 16461960 BACKGROUND

• Kline JA, Mitchell AM, Kabrhel C, Richman PB, Courtney DM. Clinical criteria to prevent unnecessary diagnostic testing in emergency department patients with suspected pulmonary embolism. J Thromb Haemost. 2004 Aug;2(8):1247-55. doi: 10.1111/j.1538-7836.2004.00790.x.

  PMID: 15304025 BACKGROUND

• Havas S. The ACCORD Trial and control of blood glucose level in type 2 diabetes mellitus: time to challenge conventional wisdom. Arch Intern Med. 2009 Jan 26;169(2):150-4. doi: 10.1001/archinternmed.2008.518. No abstract available.

  PMID: 19171811 BACKGROUND

• 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.

  PMID: 22923432 BACKGROUND

• Pollack CV, Schreiber D, Goldhaber SZ, Slattery D, Fanikos J, O'Neil BJ, Thompson JR, Hiestand B, Briese BA, Pendleton RC, Miller CD, Kline JA. Clinical characteristics, management, and outcomes of patients diagnosed with acute pulmonary embolism in the emergency department: initial report of EMPEROR (Multicenter Emergency Medicine Pulmonary Embolism in the Real World Registry). J Am Coll Cardiol. 2011 Feb 8;57(6):700-6. doi: 10.1016/j.jacc.2010.05.071.

  PMID: 21292129 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Pulmonary Embolism

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jason Stopyra, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 11, 2018
• Study Start: April 18, 2018
• Primary Completion: February 18, 2019
• Study Completion: September 9, 2020
• Last Updated: July 25, 2023

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)