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Low-Risk Chest Pain Echo Study

Primary Purpose

Chest Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Point-of-Care Echocardiogram
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Echo Arm

    Usual Care

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    February 13, 2023
    Last Updated
    March 23, 2023
    Sponsor
    University of Kansas Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05785923
    Brief Title
    Low-Risk Chest Pain Echo Study
    Official Title
    The Impact of Point-of-Care Ultrasound Echocardiography on the Disposition of Low-Risk Chest Pain Patients in the Emergency Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 5, 2023 (Anticipated)
    Primary Completion Date
    July 30, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Kansas Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chest Pain

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Echo Arm
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Chest pain patients identified by their treating physician as being low-risk chest pain will receive the usual care for their condition.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Point-of-Care Echocardiogram
    Intervention Description
    Four view ultrasound of the heart performed at the bedside by trained emergency medicine physicians.
    Primary Outcome Measure Information:
    Title
    Disposition
    Description
    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.
    Time Frame
    Day of enrollment
    Secondary Outcome Measure Information:
    Title
    Follow up instructions
    Description
    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.
    Time Frame
    day of enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adrienne Malik, MD
    Phone
    913-588-6504
    Email
    amalik3@kumc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lucas Lemar
    Email
    llemar@kumc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30718010
    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.
    Results Reference
    background
    PubMed Identifier
    27390945
    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.
    Results Reference
    background
    PubMed Identifier
    33397050
    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.
    Results Reference
    background
    PubMed Identifier
    30413369
    Citation
    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.
    Results Reference
    background

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    Low-Risk Chest Pain Echo Study

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