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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05785923
Other study ID # STUDY00149603
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 5, 2023
Est. completion date November 30, 2023

Study information

Verified date March 2023
Source University of Kansas Medical Center
Contact Adrienne Malik, MD
Phone 913-588-6504
Email amalik3@kumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date November 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Point-of-Care Echocardiogram
Four view ultrasound of the heart performed at the bedside by trained emergency medicine physicians.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Kansas Medical Center

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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