Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain (ENDEMIC)
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Petr Grenar, MD
- Telefoonnummer: +420724027318
- E-mail: petr.grenar@fnhk.cz
Studie Contact Back-up
- Naam: Martin Jakl, assoc.prof.
- Telefoonnummer: +420607514962
- E-mail: martin.jakl@fnhk.cz
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: FOCUS group
Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ). Patients with odd registration number. |
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.
|
|
Actieve vergelijker: Non-FOCUS group
Patients with even registration number.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time of patient stay at Emergency Department
Tijdsspanne: 24 hours
|
Time from initial contact with patient to patient discharge or hospital admission (minutes)
|
24 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time of stay at hospital
Tijdsspanne: 28 days
|
Time from hospital admission to hospital discharge (hours)
|
28 days
|
|
Major adverse cardiovascular events
Tijdsspanne: 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).
|
30 days
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to Coronary Angiography
Tijdsspanne: 365 days
|
Time from initial contact to coronary angiography (days)
|
365 days
|
|
Accuracy of thoracic ultrasound exam provided by non-cardiologist
Tijdsspanne: 30 days
|
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
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Martin Jakl, assoc.prof., University of Defense, Faculty of Military Health Sciences, Czech Republic
- Hoofdonderzoeker: Petr Grenar, MD, University of Defense, Faculty of Military Health Sciences, Czech Republic
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0000-0001-9433-296X
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
To be shared:
- baseline characteristics of study population
- data related to primary and secondary endpoints
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
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