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

NCT ID: NCT05306730

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-01-01

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

Conditions

Cardiology; Acute Coronary Syndrome; Echocardiography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FOCUS group

Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ).

Patients with odd registration number.

Group Type: EXPERIMENTAL

ECHOcardiography, Point-of-Care UZ

Intervention Type: DEVICE

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.

Non-FOCUS group

Patients with even registration number.

Group Type: ACTIVE_COMPARATOR

ECHOcardiography, Point-of-Care UZ

Intervention Type: DEVICE

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.

Interventions

ECHOcardiography, 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Defence, Faculty of Military Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Petr GRENAR, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Jakl, assoc.prof.

Role: STUDY_DIRECTOR

University of Defense, Faculty of Military Health Sciences, Czech Republic

Petr Grenar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Defense, Faculty of Military Health Sciences, Czech Republic

Central Contacts

Petr Grenar, MD

Role: CONTACT

petr.grenar@fnhk.cz

+420724027318

Martin Jakl, assoc.prof.

Role: CONTACT

martin.jakl@fnhk.cz

+420607514962

References

Grenar 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.

Reference Type: DERIVED

PMID: 38222095 (View on PubMed)

Other Identifiers

0000-0001-9433-296X

Identifier Type: -

Identifier Source: org_study_id