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Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain (ENDEMIC)

Primary Purpose

Cardiology, Acute Coronary Syndrome, Echocardiography

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ECHOcardiography, Point-of-Care UZ
Sponsored by
University of Defence, Faculty of Military Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiology focused on measuring Echocardiography, Point-of-care ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chest pain ( Cardiovascular ethiology possible depends on anamnesis, physical examination and ECG )
  • Higher age than 18

Exclusion Criteria:

  • STEMI
  • Pacemaker / ICD
  • Pregnancy
  • Performance status 4 ( Zubrod scale )
  • Informed Consent unsigned
  • Prisoners

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    FOCUS group

    Non-FOCUS group

    Arm Description

    Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ). Patients with odd registration number.

    Patients with even registration number.

    Outcomes

    Primary Outcome Measures

    Time of patient stay at Emergency Department
    Time from initial contact with patient to patient discharge or hospital admission (minutes)

    Secondary Outcome Measures

    Time of stay at hospital
    Time from hospital admission to hospital discharge (hours)
    Major adverse cardiovascular events
    Major adverse cardiovascular events are defined as composite endpoint of cardiovascular death, nonfatal myocardial infarction or unscheduled hospitalization due to cardiovascular disease (percent of patients in study groups).

    Full Information

    First Posted
    February 14, 2022
    Last Updated
    March 22, 2022
    Sponsor
    University of Defence, Faculty of Military Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05306730
    Brief Title
    Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain
    Acronym
    ENDEMIC
    Official Title
    Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Defence, Faculty of Military Health Sciences

    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
    The aim of the study is to find out the benefit of echocardiography, which is performed by a physican without a cardiological or radiological specialty. In this case the echocardiography is used in the first contact with a patient with chest pain of unclear etiology. Possible benefit is rapid risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection.
    Detailed Description
    Emergent echocardiography is reproducible method providing clinically significant information during primary survey of acute cardiovascular diseases. Possible benefit is the risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection. Step one - Education in Cardiac ultrasound. All physicians involved in ENDEMIC study have to undergo education program of heart ultrasonography. This curriculum fulfills BSE level one requirements. Candidates of this program have to make a defined number of ECHOcardiography studies under supervisor control. Every curriculum is finished by exam. Step two - FOCUS in clinical practise Patients with chest pain are randomized into two groups by the even-odd rule. Inclusion Criteria: Chest pain ( Cardiovascular ethiology possible depends on anamnesis, physical examination and ECG ) Higher age than 18 Exclusion Criteria: STEMI Pacemaker / ICD Pregnancy Performance status 4 ( Zubrod scale ) Informed Consent unsigned Prisoners Step Three - Evaluation Aims.: Compare time to make a decision in these groups Compare time of stay at emergency department in these groups Compare time to invasive coronary angiography and revascularization (if available) Compare time to hospital dimission Occurrence of MACE in following 30 days

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiology, Acute Coronary Syndrome, Echocardiography
    Keywords
    Echocardiography, Point-of-care ultrasound

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    FOCUS group
    Arm Type
    Experimental
    Arm Description
    Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ). Patients with odd registration number.
    Arm Title
    Non-FOCUS group
    Arm Type
    Active Comparator
    Arm Description
    Patients with even registration number.
    Intervention Type
    Device
    Intervention Name(s)
    ECHOcardiography, Point-of-Care UZ
    Intervention Description
    Emergent echocardiography is reproducible method providing clinically significant information during primary survey of acute cardiovascular diseases. Possible benefit is the risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection. The aim of interest is to consider riscs and benefits of the ultrasound of heart done by non-cardiologist after standardized course.
    Primary Outcome Measure Information:
    Title
    Time of patient stay at Emergency Department
    Description
    Time from initial contact with patient to patient discharge or hospital admission (minutes)
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Time of stay at hospital
    Description
    Time from hospital admission to hospital discharge (hours)
    Time Frame
    28 days
    Title
    Major adverse cardiovascular events
    Description
    Major adverse cardiovascular events are defined as composite endpoint of cardiovascular death, nonfatal myocardial infarction or unscheduled hospitalization due to cardiovascular disease (percent of patients in study groups).
    Time Frame
    30 days
    Other Pre-specified Outcome Measures:
    Title
    Time to Coronary Angiography
    Description
    Time from initial contact to coronary angiography (days)
    Time Frame
    365 days
    Title
    Accuracy of thoracic ultrasound exam provided by non-cardiologist
    Description
    All echocardiography records will be revised by skilled echocardiographist to assess the accuracy of performed examinations. All missed or erroneous finding resulting in alteration of patient management (especially wall motion abnormity, valvular disease and pericardial effusion) will be calculated. (quantity of erroneous or missed findings per record)
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chest pain ( Cardiovascular ethiology possible depends on anamnesis, physical examination and ECG ) Higher age than 18 Exclusion Criteria: STEMI Pacemaker / ICD Pregnancy Performance status 4 ( Zubrod scale ) Informed Consent unsigned Prisoners
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Petr Grenar, MD
    Phone
    +420724027318
    Email
    petr.grenar@fnhk.cz
    First Name & Middle Initial & Last Name or Official Title & Degree
    Martin Jakl, assoc.prof.
    Phone
    +420607514962
    Email
    martin.jakl@fnhk.cz
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Martin Jakl, assoc.prof.
    Organizational Affiliation
    University of Defense, Faculty of Military Health Sciences, Czech Republic
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Petr Grenar, MD
    Organizational Affiliation
    University of Defense, Faculty of Military Health Sciences, Czech Republic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    To be shared: baseline characteristics of study population data related to primary and secondary endpoints
    IPD Sharing Time Frame
    Available 1 year after completing the study, for at least 10 years
    IPD Sharing Access Criteria
    Contact principal investigator

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