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

22. marts 2022 opdateret af: Petr GRENAR, MD, University of Defence, Faculty of Military Health Sciences
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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

430

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: FOCUS group

Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ).

Patients with odd registration number.
Enhed: 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.
Aktiv komparator: Non-FOCUS group
Patients with even registration number.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time of patient stay at Emergency Department
Tidsramme: 24 hours
Time from initial contact with patient to patient discharge or hospital admission (minutes)
24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time of stay at hospital
Tidsramme: 28 days
Time from hospital admission to hospital discharge (hours)
28 days
Major adverse cardiovascular events
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Coronary Angiography
Tidsramme: 365 days
Time from initial contact to coronary angiography (days)
365 days
Accuracy of thoracic ultrasound exam provided by non-cardiologist
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Defence, Faculty of Military Health Sciences

Efterforskere

  • Studieleder: Martin Jakl, assoc.prof., University of Defense, Faculty of Military Health Sciences, Czech Republic
  • Ledende efterforsker: Petr Grenar, MD, University of Defense, Faculty of Military Health Sciences, Czech Republic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. maj 2022

Primær færdiggørelse (Forventet)

1. september 2023

Studieafslutning (Forventet)

1. januar 2024

Datoer for studieregistrering

Først indsendt

14. februar 2022

Først indsendt, der opfyldte QC-kriterier

22. marts 2022

Først opslået (Faktiske)

1. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0000-0001-9433-296X

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

To be shared:

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

IPD-delingstidsramme

Available 1 year after completing the study, for at least 10 years

IPD-delingsadgangskriterier

Contact principal investigator

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Akut koronarsyndrom

Kliniske forsøg med ECHOcardiography, Point-of-Care UZ

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