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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Coronary Syndrome; Echocardiography; Cardiology
• Intervention / Treatment: Device: ECHOcardiography, Point-of-Care UZ

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 Type: Interventional
• Enrollment (Anticipated): 430
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petr Grenar, MD; Phone Number: +420724027318; Email: petr.grenar@fnhk.cz
• Study Contact Backup: Name: Martin Jakl, assoc.prof.; Phone Number: +420607514962; Email: martin.jakl@fnhk.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FOCUS group; Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ). Patients with odd registration number.	Device: 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.
Active Comparator: Non-FOCUS group; Patients with even registration number.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of patient stay at Emergency Department	Time from initial contact with patient to patient discharge or hospital admission (minutes)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of stay at hospital	Time from hospital admission to hospital discharge (hours)	28 days
Major adverse cardiovascular events	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).	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Coronary Angiography	Time from initial contact to coronary angiography (days)	365 days
Accuracy of thoracic ultrasound exam provided by non-cardiologist	All 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)	30 days

Collaborators and Investigators

• Sponsor: University of Defence, Faculty of Military Health Sciences
• Investigators: Study Director: Martin Jakl, assoc.prof., University of Defense, Faculty of Military Health Sciences, Czech Republic; Principal Investigator: Petr Grenar, MD, University of Defense, Faculty of Military Health Sciences, Czech Republic

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Point-of-care ultrasound; Echocardiography
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: 0000-0001-9433-296X

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

To be shared:

• baseline characteristics of study population
• data related to primary and secondary endpoints

• IPD Sharing Time Frame: Available 1 year after completing the study, for at least 10 years
• IPD Sharing Access Criteria: Contact principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No