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

Not Applicable

• Conditions: Echocardiography; Cardiology; Acute Coronary Syndrome
• Interventions: Device: ECHOcardiography, Point-of-Care UZ

• Registration Number: NCT05306730
• Lead Sponsor: University of Defence, Faculty of Military Health Sciences

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

Study Timeline

• Study First Submitted: 2022-02-14
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-22
• Last Update Submitted: 2022-03-22
• Study First Posted: 2022-04-01
• Last Update Posted: 2022-04-01
• Study Start: 2022-05-01
• Primary Completion: 2023-09-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 430

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOCUS group	ECHOcardiography, Point-of-Care UZ	Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ). Patients with odd registration number.
Non-FOCUS group	ECHOcardiography, Point-of-Care UZ	Patients with even registration number.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
Time of stay at hospital	28 days	Time from hospital admission to hospital discharge (hours)