CardiologyENDEMICNCT05306730
Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain
A study testing ECHOcardiography, Point-of-Care UZ in people with Cardiology and Acute Coronary Syndrome, run by University of Defence, Faculty of Military Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiology, Acute Coronary Syndrome, Echocardiography
- What is being tested?
- ECHOcardiography, Point-of-Care UZ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chest pain ( Cardiovascular ethiology possible depends on anamnesis, physical examination and ECG )
- Higher age than 18
Who cannot join
- STEMI
- Pacemaker / ICD
- Pregnancy
- Performance status 4 ( Zubrod scale )
- Informed Consent unsigned
- Prisoners
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Conditions
- Cardiology, Acute Coronary Syndrome, Echocardiography
- Being tested
- ECHOcardiography, Point-of-Care UZ
- Keywords
- Echocardiography, Point-of-care ultrasound
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHOcardiography, Point-of-Care UZDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| FOCUS group | Experimental | Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ).
Patients with odd registration number. Receives: Device: ECHOcardiography, Point-of-Care UZ |
| Non-FOCUS group | Active comparator | Patients with even registration number. Receives: Device: ECHOcardiography, Point-of-Care UZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of patient stay at Emergency Department
Time from initial contact with patient to patient discharge or hospital admission (minutes)
Measured: 24 hours
Secondary outcomes (2)
Time of stay at hospital
Time from hospital admission to hospital discharge (hours)
Measured: 28 days
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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CardiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Defence, Faculty of Military Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr GRENAR, MD, University of Defence, Faculty of Military Health Sciences
- Investigators
- Martin Jakl, assoc.prof., Study director, University of Defense, Faculty of Military Health Sciences, Czech RepublicPetr Grenar, MD, Principal investigator, University of Defense, Faculty of Military Health Sciences, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306730
- Sponsor's protocol ID
- 0000-0001-9433-296X
- Acronym
- ENDEMIC
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be shared: * baseline characteristics of study population * data related to primary and secondary endpoints
Publications
Grenar P, Jakl M, Medilek K, Novy J, Koci J, Vanek J, Cermakova M, Horacek JM, Pudil R. Effect of point-of-care echocardiography by noncardiologists on patient management in acute chest pain. Intern Emerg Med. 2025 Nov 24. doi: 10.1007/s11739-025-04198-6. Online ahead of print.
PubMed 41284127Grenar P, Novy J, Medilek K, Jakl M. Point-of-Care Cardiac Ultrasound Training Programme: Experience from the University Hospital Hradec Kralove. Emerg Med Int. 2024 Jan 6;2024:9974284. doi: 10.1155/2024/9974284. eCollection 2024.
PubMed 38222095
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain
- ClinicalTrials.gov ID
- NCT05306730
- Acronym / sponsor ID
- ENDEMIC / 0000-0001-9433-296X
- Conditions
- Cardiology, Acute Coronary Syndrome, Echocardiography
- Keywords
- Echocardiography, Point-of-care ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- University of Defence, Faculty of Military Health SciencesUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOCUS group | Experimental | Device: ECHOcardiography, Point-of-Care UZGroup of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ). Patients with odd registration number. |
| Non-FOCUS group | Active comparator | Device: ECHOcardiography, Point-of-Care UZPatients with even registration number. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chest pain ( Cardiovascular ethiology possible depends on anamnesis, physical examination and ECG )
- Higher age than 18
Key exclusion criteria (6 listed)
- STEMI
- Pacemaker / ICD
- Pregnancy
- Performance status 4 ( Zubrod scale )
- Informed Consent unsigned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECHOcardiography, Point-of-Care UZEmergent 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. | Device | FOCUS group, Non-FOCUS group |
Primary outcome
Time of patient stay at Emergency Department
Time frame: 24 hours
Time from initial contact with patient to patient discharge or hospital admission (minutes)
2 secondary outcomes
Time of stay at hospital
Time frame: 28 days
Major adverse cardiovascular events
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Derived from this study: PubMed 41284127Grenar P, Jakl M, Medilek K, Novy J, Koci J, Vanek J, Cermakova M, Horacek JM, Pudil R. Effect of point-of-care echocardiography by noncardiologists on patient management in acute chest pain. Intern Emerg Med. 2025 Nov 24. doi: 10.1007/s11739-025-04198-6. Online ahead of print.
- Derived from this study: PubMed 38222095Grenar P, Novy J, Medilek K, Jakl M. Point-of-Care Cardiac Ultrasound Training Programme: Experience from the University Hospital Hradec Kralove. Emerg Med Int. 2024 Jan 6;2024:9974284. doi: 10.1155/2024/9974284. eCollection 2024.
- Individual participant dataSharing planned: Yes. To be shared: * baseline characteristics of study population * data related to primary and secondary endpoints
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Jakl, assoc.prof. study director
University of Defense, Faculty of Military Health Sciences, Czech Republic
Petr Grenar, MD principal investigator
University of Defense, Faculty of Military Health Sciences, Czech Republic
Questions about this trial
What is this clinical trial studying?
A study testing ECHOcardiography, Point-of-Care UZ in people with Cardiology and Acute Coronary Syndrome, run by University of Defence, Faculty of Military Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petr Grenar, MD (+420724027318, petr.grenar@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of patient stay at Emergency Department (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306730, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.