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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05306730
Acronym
ENDEMIC
Enrollment
430
Registered
2022-04-01
Start date
2022-05-01
Completion date
2024-01-01
Last updated
2022-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Cardiology, Echocardiography

Keywords

Echocardiography, Point-of-care ultrasound

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

Interventions

DEVICEECHOcardiography, 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.

Sponsors

University of Defence, Faculty of Military Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Time of patient stay at Emergency Department24 hoursTime from initial contact with patient to patient discharge or hospital admission (minutes)

Secondary

MeasureTime frameDescription
Time of stay at hospital28 daysTime from hospital admission to hospital discharge (hours)
Major adverse cardiovascular events30 daysMajor 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

MeasureTime frameDescription
Time to Coronary Angiography365 daysTime from initial contact to coronary angiography (days)
Accuracy of thoracic ultrasound exam provided by non-cardiologist30 daysAll 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)

Contacts

Primary ContactPetr Grenar, MD
petr.grenar@fnhk.cz+420724027318
Backup ContactMartin Jakl, assoc.prof.
martin.jakl@fnhk.cz+420607514962

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026