- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03494556
Prehospital Translation of Chest Pain Tools (RESCUE)
July 21, 2023 updated by: Wake Forest University Health Sciences
Translating Evidence-Based Chest Pain Decision Aids to the Prehospital Environment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To accomplish our Specific Aims the study team proposes a prospective, observational pilot study of four rapid risk stratification tools, the HEART Pathway Score, EDACS score, revised Geneva score, and PERC score, among 250 chest pain patients within two large EMS systems.
The proposed pilot study has broad-based support from local and state EMS agencies, including Cumberland and New Hanover County EMS agencies.
Each tool will be pilot tested and compared in the prehospital setting for feasibility and accuracy.
Paramedics will be trained in risk stratification tool use and then will prospectively collect the clinical data needed to calculate each risk stratification score when caring for adults with chest pain.
Completed paramedic risk assessments will be used to determine feasibility.
Patients will be followed for 30 days to determine occurrence of ACS and PE events and the sensitivity of each risk stratification decision aid will be determined.
Study Type
Observational
Enrollment (Actual)
365
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
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Fayetteville, North Carolina, United States, 28304
- Cape Fear Valley Mobile Integrated Healthcare Cumberland County EMS
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Wilmington, North Carolina, United States, 28401
- New Hanover Regional Medical Center EMS
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients being transported to the Emergency Department by Cumberland or New Hanover County EMS.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with evidence of ST elevation myocardial infarction (STEMI) on ECG
- Inter-facility transports (transfers)
- Patients with unstable vital signs
- Prisoners
- Non-english speakers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
No Intervention
Paramedic will use data collected during routine care to complete four risk stratification tools.
|
Paramedic will use data collected during routine care to complete four risk stratification tools.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine whether prehospital chest pain decision aid use is feasible.
Time Frame: 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare decision aids to determine which are the most sensitive and specific
Time Frame: 30 days
|
Destination hospitals have well established linkages between the prehospital and hospital Electronic Medical Record (EMR) facilitating patient outcome ascertainment.
Data will be abstracted from the EMR to determine occurrence of 30 day study outcomes.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jason Stopyra, MD, Wake Forest University Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2018
Primary Completion (Actual)
February 18, 2019
Study Completion (Actual)
September 9, 2020
Study Registration Dates
First Submitted
April 3, 2018
First Submitted That Met QC Criteria
April 10, 2018
First Posted (Actual)
April 11, 2018
Study Record Updates
Last Update Posted (Actual)
July 25, 2023
Last Update Submitted That Met QC Criteria
July 21, 2023
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00048904
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
At this time, the study does not have plans to share individual participant data, including data dictionaries, with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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