Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain (ENDEMIC)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Petr Grenar, MD
- Telefonnummer: +420724027318
- E-post: petr.grenar@fnhk.cz
Studera Kontakt Backup
- Namn: Martin Jakl, assoc.prof.
- Telefonnummer: +420607514962
- E-post: martin.jakl@fnhk.cz
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv komparator: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time of patient stay at Emergency Department
Tidsram: 24 hours
|
Time from initial contact with patient to patient discharge or hospital admission (minutes)
|
24 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time of stay at hospital
Tidsram: 28 days
|
Time from hospital admission to hospital discharge (hours)
|
28 days
|
|
Major adverse cardiovascular events
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to Coronary Angiography
Tidsram: 365 days
|
Time from initial contact to coronary angiography (days)
|
365 days
|
|
Accuracy of thoracic ultrasound exam provided by non-cardiologist
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Studierektor: Martin Jakl, assoc.prof., University of Defense, Faculty of Military Health Sciences, Czech Republic
- Huvudutredare: Petr Grenar, MD, University of Defense, Faculty of Military Health Sciences, Czech Republic
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0000-0001-9433-296X
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
To be shared:
- baseline characteristics of study population
- data related to primary and secondary endpoints
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- CSR
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