Low-Risk Chest Pain Echo Study

The Impact of Point-of-Care Ultrasound Echocardiography on the Disposition of Low-Risk Chest Pain Patients in the Emergency Department

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chest Pain
• Intervention / Treatment: Diagnostic test: Point-of-Care Echocardiogram

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrienne Malik, MD; Phone Number: 913-588-6504; Email: amalik3@kumc.edu
• Study Contact Backup: Name: Lucas Lemar; Email: llemar@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Echo Arm; 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; Four view ultrasound of the heart performed at the bedside by trained emergency medicine physicians.
No Intervention: Usual Care; Chest pain patients identified by their treating physician as being low-risk chest pain will receive the usual care for their condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow up instructions	Will assess if the result of the point-of-care echocardiogram changed the follow up instructions or discharge medication decision for the enrolled subject as determined by the physician of record by asking them if the echo results caused them to add any additional discharge instructions for the patient. We will record their answer on the IRB approved data collection sheet.	day of enrollment

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 5, 2023
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: STUDY00149603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No