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

Acute Coronary Syndrome Clinical Trial

— ENDEMIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05306730
• Other study ID #: 0000-0001-9433-296X
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2022
• Source: University of Defence, Faculty of Military Health Sciences
• Contact: Petr Grenar, MD
• Phone: +420724027318
• Email: petr.grenar[@]fnhk.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 430
• Est. completion date: January 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiology
• Chest Pain
• Echocardiography

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Defence, Faculty of Military Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to Coronary Angiography	Time from initial contact to coronary angiography (days)	365 days
Other	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
Primary	Time of patient stay at Emergency Department	Time from initial contact with patient to patient discharge or hospital admission (minutes)	24 hours
Secondary	Time of stay at hospital	Time from hospital admission to hospital discharge (hours)	28 days
Secondary	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