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Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study

28. maj 2026 opdateret af: University of Alberta
This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of AI-assisted point of care echocardiography on HF detection and downstream care processes for patients with suspected HF discharged from the Emergency Department.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Heart failure remains underdiagnosed in frontline care settings, in part due to limited access to timely echocardiography. Recent advances in artificial intelligence (AI)-assisted echocardiography may facilitate scalable bedside screening through automated image acquisition support and interpretation.

This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of routine implementation of AI-assisted point of care echocardiography on HF detection and downstream processes of care for patients with suspected HF being discharged from the Emergency Department.

This study will be carried out at 2 participating Emergency Departments (EDs) in Alberta, Canada. Each ED site will alternate monthly between Intervention (AI-assisted echocardiography) and Control (Usual Care) periods.

During intervention periods, patients with suspected HF will undergo AI-assisted echocardiography using a handheld point of care EchoNous Kosmos device by the treating ED physician. The US2.ai algorithm will generate an AI-automated echo report. During control periods, patients will be managed according to usual care.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

84

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

  • Navn: Clinical Trials Project Lead
  • Telefonnummer: 1-800-707-9098
  • E-mail: aa2i2@ualberta.ca

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Adult patients age ≥18 years presenting to the emergency department (ED);
  2. with signs or symptoms of HF as per the treating physician and
  3. elevated natriuretic peptides (NT-proBNP >125pg/mL or BNP >50pg/mL), drawn as part of standard of care of evaluation in the ED.

Exclusion Criteria:

  1. prior documented diagnosis of HF;
  2. any patient receiving renal replacement therapy;
  3. any patient receiving comfort or palliative care;
  4. pregnant or nursing patients;
  5. patient is planned for admission.

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: Sekventiel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
During each month-long Intervention period, an AI-assisted POCUS tool will be available for ED physicians use, at their discretion, to assess left ventricular ejection fraction (LVEF) and diastolic function in patients presenting to the ED with suspected HF. The AI-automated echocardiogram report may be used in the referral pathway to the HF clinic if deemed clinically appropriate.
Enhed: AI-assisted point-of-care ultrasound (POCUS)

ED physicians at both sites will be provided with 1 session of in person training in the use of the AI-assisted POCUS device within 4 weeks of randomization including,

  • Device set up
  • Demo of patient exam with POCUS device (to be used within its CE/Health Canada marked intended purpose or where deemed clinically appropriate by the treating physician).
  • Generation of AI-automated echocardiogram report for LVEF and diastolic dysfunction.
Ingen indgriben: Control Period (Usual Care)
During each month-long Control period, the ED physicians will manage patients as close to "true" usual care as possible. There is no "placebo" arm. No actions will be undertaken to impede or prohibit care in the usual care arm.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of AI Assisted Point of Care Echocardiography Implementation
Tidsramme: During the enrollment period.
Proportion of eligible patients successfully undergoing AI assisted echo assessment at the point of care.
During the enrollment period.

Sekundære resultatmål

Resultatmål
Tidsramme
Diagnosis of heart failure (HF) within 90 days
Tidsramme: At 90 days.
At 90 days.
Downstream health care resource utilization at 90 days and 1 year (e.g. rates of requests for echocardiography, cardiology referral, primary care appointments, HF hospitalization).
Tidsramme: At 90 days and 1 year.
At 90 days and 1 year.
Proportion of patients with HF receiving GDMT within 90 days
Tidsramme: At 90 days.
At 90 days.
Difference in ratio of the incidence of diagnoses of HF via hospital admission-based versus community-based pathways
Tidsramme: At 90 days.
At 90 days.
Uptake and utilization: differential rates of uptake and utilization of AI Assisted echocardiography in the emergency department
Tidsramme: During the enrollment period.
During the enrollment period.
Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire)
Tidsramme: During the enrollment period.
During the enrollment period.

Samarbejdspartnere og efterforskere

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

Sponsor

University of Alberta

Samarbejdspartnere

Canadian VIGOUR Centre

Efterforskere

  • Ledende efterforsker: Justin Ezekowitz, MD, University of Alberta
  • Ledende efterforsker: Safia Chatur, MD, Massachusetts General Hospital/Harvard Medical School and University of Alberta

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 (Anslået)

25. juni 2026

Primær færdiggørelse (Anslået)

15. august 2027

Studieafslutning (Anslået)

14. august 2028

Datoer for studieregistrering

Først indsendt

25. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A2I2HF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

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 Hjertefejl

Kliniske forsøg med AI-assisted point-of-care ultrasound (POCUS)

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