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

Sponsor
University of Defence, Faculty of Military Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05306730
Collaborator
(none)
430
2
20

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ECHOcardiography, Point-of-Care UZ
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
430 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: FOCUS group

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

Device: ECHOcardiography, Point-of-Care UZ
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.

Active Comparator: Non-FOCUS group

Patients with even registration number.

Device: ECHOcardiography, Point-of-Care UZ
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.

Outcome Measures

Primary Outcome Measures

  1. Time of patient stay at Emergency Department [24 hours]

    Time from initial contact with patient to patient discharge or hospital admission (minutes)

Secondary Outcome Measures

  1. Time of stay at hospital [28 days]

    Time from hospital admission to hospital discharge (hours)

  2. Major adverse cardiovascular events [30 days]

    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).

Other Outcome Measures

  1. Time to Coronary Angiography [365 days]

    Time from initial contact to coronary angiography (days)

  2. Accuracy of thoracic ultrasound exam provided by non-cardiologist [30 days]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Defence, Faculty of Military Health Sciences

Investigators

  • Study Director: Martin Jakl, assoc.prof., University of Defense, Faculty of Military Health Sciences, Czech Republic
  • Principal Investigator: Petr Grenar, MD, University of Defense, Faculty of Military Health Sciences, Czech Republic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Petr GRENAR, MD, Principal Investigator, University of Defence, Faculty of Military Health Sciences
ClinicalTrials.gov Identifier:
NCT05306730
Other Study ID Numbers:
  • 0000-0001-9433-296X
First Posted:
Apr 1, 2022
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Petr GRENAR, MD, Principal Investigator, University of Defence, Faculty of Military Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022