NCT05785923

Brief Summary

Pilot study to assess if a bedside point-of-care echocardiogram performed on emergency department patients identified as low-risk chest pain prior to discharge significantly changes patient disposition or follow up instructions.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

April 5, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

February 13, 2023

Last Update Submit

March 23, 2023

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (1)

  • Disposition

    Will assess if the result of the point-of-care echocardiogram resulted in the physician of record changing subject disposition from discharge to admission. We will assess this by asking the physician of record what the disposition plan is for the patient and recording their answer on IRB approved data collection sheet.

    Day of enrollment

Secondary Outcomes (1)

  • Follow up instructions

    day of enrollment

Study Arms (2)

Echo Arm

EXPERIMENTAL

Chest pain patients identified by their treating physician as being low-risk chest pain will undergo a point-of-care echocardiogram performed by a trained emergency medicine attending or resident prior to discharge from the emergency department. The physician of record will review this ultrasound and it will be documented whether the findings on the ultrasound changed the physician of record's disposition decision for the patient or the follow up instructions or medications.

Diagnostic Test: Point-of-Care Echocardiogram

Usual Care

NO INTERVENTION

Chest pain patients identified by their treating physician as being low-risk chest pain will receive the usual care for their condition.

Interventions

Point-of-Care EchocardiogramDIAGNOSTIC_TEST

Four view ultrasound of the heart performed at the bedside by trained emergency medicine physicians.

Echo Arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults presenting to the emergency department with an isolated chief complaint of chest pain with a HEART score of 3 or less
  • Emergency physician of record has decided to discharge this patient from the Emergency Department

You may not qualify if:

  • Patients who are unable to consent for themselves
  • History of cardiac transplant or LVAD
  • Pediatric patients
  • Patients presenting with multiple complaints in addition to chest pain
  • Echocardiogram already performed on patient during usual care
  • Patients with another non-cardiac admittable diagnosis
  • HEART score greater than or equal to 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Laureano-Phillips J, Robinson RD, Aryal S, Blair S, Wilson D, Boyd K, Schrader CD, Zenarosa NR, Wang H. HEART Score Risk Stratification of Low-Risk Chest Pain Patients in the Emergency Department: A Systematic Review and Meta-Analysis. Ann Emerg Med. 2019 Aug;74(2):187-203. doi: 10.1016/j.annemergmed.2018.12.010. Epub 2019 Feb 2.

    PMID: 30718010BACKGROUND

  • Rainer TH, Leung YK, Lee A, Chan PY, Cheng NM, Wong JK, Yan BP, Ahuja AT, Graham CA. Add-on tests for improving risk-stratification in emergency department patients with chest pain who are at low to moderate risk of 30-day major adverse cardiac events. Int J Cardiol. 2016 Oct 1;220:299-306. doi: 10.1016/j.ijcard.2016.05.057. Epub 2016 May 14.

    PMID: 27390945BACKGROUND

  • Guner NG, Yurumez Y, Yucel M, Alacam M, Guner ST, Ercan B. Effects of Point-of-care Ultrasonography on the Diagnostic Process of Patients Admitted to the Emergency Department with Chest Pain: A Randomised Controlled Trial. J Coll Physicians Surg Pak. 2020 Dec;30(12):1262-1268. doi: 10.29271/jcpsp.2020.12.1262.

    PMID: 33397050BACKGROUND

  • Buhumaid RE, St-Cyr Bourque J, Shokoohi H, Ma IWY, Longacre M, Liteplo AS. Integrating point-of-care ultrasound in the ED evaluation of patients presenting with chest pain and shortness of breath. Am J Emerg Med. 2019 Feb;37(2):298-303. doi: 10.1016/j.ajem.2018.10.059. Epub 2018 Oct 30.

    PMID: 30413369BACKGROUND

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Adrienne Malik, MD

CONTACT

913-588-6504amalik3@kumc.edu

Lucas Lemar

CONTACT

llemar@kumc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 27, 2023

Study Start

April 5, 2023

Primary Completion

July 30, 2023

Study Completion

November 30, 2023

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share