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Acute Coronary SyndromeRESCUENCT03494556

Prehospital Translation of Chest Pain Tools

An observational study of Acute Coronary Syndrome and Pulmonary Embolism, run by Wake Forest University Health Sciences at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Acute Coronary Syndrome, Pulmonary Embolism
What is being tested?
Data Collection
How many people
365 participants
Where
2 sitesUnited States
Study dates
18 Apr 2018to 9 Sep 2020
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cape Fear Valley Mobile Integrated Healthcare Cumberland County EMS

    Fayetteville, North Carolina, 28304

  • New Hanover Regional Medical Center EMS

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Data Collection
Medical subject headings
Acute Coronary Syndrome, Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data CollectionOther

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

Study groups in NCT03494556
Study groupRoleWhat they receive
No InterventionParamedic will use data collected during routine care to complete four risk stratification tools.
Receives: Other: Data Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 hours

Secondary outcomes (1)

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

    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.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2018
  2. Study start18 Apr 2018
  3. Primary completion18 Feb 2019
  4. Study completion9 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
365 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03494556
Sponsor's protocol ID
IRB00048904
Acronym
RESCUE
Status last verified
Oct 2019
First submitted
3 Apr 2018
Last updated
25 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: At this time, the study does not have plans to share individual participant data, including data dictionaries, with other researchers.

Publications

  • 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.

    PubMed 20074834

  • 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.

    PubMed 21367333

  • 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.

    PubMed 25209450

  • 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.

    PubMed 19367468

  • 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.

    PubMed 21777448

  • 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.

    PubMed 23117012

  • 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.

    PubMed 25737484

  • 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.

    PubMed 24731933

  • 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.

    PubMed 21989033

  • 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.

    PubMed 27406833

  • 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.

    PubMed 24428678

  • 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.

    PubMed 16461960

  • 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.

    PubMed 15304025

  • 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.

    PubMed 19171811

  • 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.

    PubMed 22923432

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Pulmonary Embolism, run by Wake Forest University Health Sciences at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine whether prehospital chest pain decision aid use is feasible. (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03494556, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.

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