Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain (ENDEMIC)
Primary Purpose
Cardiology, Acute Coronary Syndrome, Echocardiography
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ECHOcardiography, Point-of-Care UZ
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiology focused on measuring Echocardiography, Point-of-care ultrasound
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FOCUS group
Non-FOCUS group
Arm Description
Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ). Patients with odd registration number.
Patients with even registration number.
Outcomes
Primary Outcome Measures
Time of patient stay at Emergency Department
Time from initial contact with patient to patient discharge or hospital admission (minutes)
Secondary Outcome Measures
Time of stay at hospital
Time from hospital admission to hospital discharge (hours)
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).
Full Information
NCT ID
NCT05306730
First Posted
February 14, 2022
Last Updated
March 22, 2022
Sponsor
University of Defence, Faculty of Military Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05306730
Brief Title
Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain
Acronym
ENDEMIC
Official Title
Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Defence, Faculty of Military Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiology, Acute Coronary Syndrome, Echocardiography
Keywords
Echocardiography, Point-of-care ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOCUS group
Arm Type
Experimental
Arm Description
Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ).
Patients with odd registration number.
Arm Title
Non-FOCUS group
Arm Type
Active Comparator
Arm Description
Patients with even registration number.
Intervention Type
Device
Intervention Name(s)
ECHOcardiography, Point-of-Care UZ
Intervention 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. The aim of interest is to consider riscs and benefits of the ultrasound of heart done by non-cardiologist after standardized course.
Primary Outcome Measure Information:
Title
Time of patient stay at Emergency Department
Description
Time from initial contact with patient to patient discharge or hospital admission (minutes)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time of stay at hospital
Description
Time from hospital admission to hospital discharge (hours)
Time Frame
28 days
Title
Major adverse cardiovascular events
Description
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 Frame
30 days
Other Pre-specified Outcome Measures:
Title
Time to Coronary Angiography
Description
Time from initial contact to coronary angiography (days)
Time Frame
365 days
Title
Accuracy of thoracic ultrasound exam provided by non-cardiologist
Description
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)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petr Grenar, MD
Phone
+420724027318
Email
petr.grenar@fnhk.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Jakl, assoc.prof.
Phone
+420607514962
Email
martin.jakl@fnhk.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Jakl, assoc.prof.
Organizational Affiliation
University of Defense, Faculty of Military Health Sciences, Czech Republic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Petr Grenar, MD
Organizational Affiliation
University of Defense, Faculty of Military Health Sciences, Czech Republic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain
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