Clinical trial NCT05306730: Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain
Official title: Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiology
Acute Coronary Syndrome
Echocardiography
Keywords: Echocardiography
Point-of-care ultrasound
Lead sponsor: University of Defence, Faculty of Military Health Sciences
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Time of patient stay at Emergency Department
timeFrame: 24 hours
Secondary outcomes:
measure: Time of stay at hospital
timeFrame: 28 days
measure: Major adverse cardiovascular events
timeFrame: 30 days
Other outcomes:
measure: Time to Coronary Angiography
timeFrame: 365 days
measure: Accuracy of thoracic ultrasound exam provided by non-cardiologist
timeFrame: 30 days
Locations:
Study officials:
affiliation: University of Defense, Faculty of Military Health Sciences, Czech Republic
name: Martin Jakl, assoc.prof.
role: STUDY_DIRECTOR
affiliation: University of Defense, Faculty of Military Health Sciences, Czech Republic
name: Petr Grenar, MD
role: PRINCIPAL_INVESTIGATOR
References: