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

University of Defence, Faculty of Military Health Sciences

Status: Unknown

Conditions: Cardiology; Acute Coronary Syndrome; Echocardiography

Treatments: Device: ECHOcardiography, Point-of-Care UZ

Study type: Interventional

Funder types: Other

Identifiers

NCT05306730

0000-0001-9433-296X

Details and patient eligibility

About

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.

Full 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

Enrollment: 430 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

FOCUS group

Experimental group

Description:

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

Treatment:

Device: ECHOcardiography, Point-of-Care UZ

Non-FOCUS group

Active Comparator group

Description:

Patients with even registration number.

Treatment:

Device: ECHOcardiography, Point-of-Care UZ