ER-VISION-AI Study (ER-VISION-AI)
21 de julho de 2026 atualizado por: Ewha Womans University Mokdong Hospital
Multimodal Visual Language Model-Assisted Diagnostic Strategy in the Emergency Department: A Prospective Multicenter Randomized Controlled Trial (ER-VISION-AI Study)
Prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE-like) clinical trial evaluating whether physician-supervised Generative Pre-trained Transformer (GPT)-assisted multimodal diagnostic support improves diagnostic concordance in emergency department patients presenting with acute cardiopulmonary symptoms.
Visão geral do estudo
Status
Ainda não está recrutando
Tipo de estudo
Intervencional
Inscrição (Estimado)
1000
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yeji Kim, PhD
- Número de telefone: +82-10-2724-7740
- E-mail: lexie6169@gmail.com
Locais de estudo
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Seoul, Coréia do Sul, 07804
- Ewha Womans University Mokdong Hospital
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Contato:
- Yeji Kim, PhD
- Número de telefone: +82-10-2724-7740
- E-mail: lexie6169@gmail.com
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Age ≥18 years
- Presentation to a participating emergency department with acute cardiopulmonary symptoms, including chest pain, dyspnea, palpitations, syncope, dizziness, or fever accompanied by cardiopulmonary symptoms
- Performance of both a standard 12-lead electrocardiogram and chest radiography during the initial emergency department evaluation
- Availability of initial clinical assessment, vital signs, laboratory findings, and all mandatory clinical information required for the multimodal AI workflow
- Expected emergency department observation or hospital admission for at least 24 hours
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Inability or refusal to provide written informed consent
- Requirement for immediate life-saving intervention that precludes completion of the study workflow
- Death before completion of the initial emergency department diagnostic assessment
- Electrocardiographic quality insufficient for reliable physician or Artificial intelligence (AI) interpretation
- Chest radiographic quality insufficient for reliable physician or Artificial intelligence (AI) interpretation
- Cardiac pacing rhythm
- Missing mandatory clinical information required for the multimodal Artificial intelligence (AI) workflow
- Previous enrollment in the ER-VISION-AI trial
- Inability to establish a blinded adjudicated reference diagnosis
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: GPT-assisted multimodal visual language model (VLM) diagnostic strategy
Participants receive physician-supervised Generative Pre-trained Transformer (GPT)-assisted multimodal diagnostic support integrating electrocardiography, chest radiography, structured clinical information, laboratory findings, vital signs, and relevant medical history.
Treating physicians remain responsible for all diagnostic and therapeutic decisions.
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A Generative Pre-trained Transformer (GPT)-based multimodal visual language model integrates electrocardiograms, chest radiographs, structured clinical information, laboratory findings, vital signs, and relevant clinical history to generate diagnostic suggestions and differential diagnoses for physician-supervised clinical decision support.
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Comparador Ativo: Conventional physician-guided diagnostic strategy
Participants undergo standard emergency department diagnostic evaluation according to routine clinical practice without Generative Pre-trained Transformer (GPT)-assisted diagnostic support.
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Routine emergency department diagnostic evaluation performed according to standard clinical practice without AI-assisted diagnostic support.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Diagnostic concordance between the final emergency department diagnosis and the blinded adjudicated reference diagnosis established at hospital discharge.
Prazo: During the index hospitalization, up to hospital discharge (average 3 days)
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Diagnostic concordance between the treating physician's final emergency department diagnosis and the blinded adjudicated reference diagnosis based on the prespecified principal diagnostic category.
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During the index hospitalization, up to hospital discharge (average 3 days)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Diagnostic concordance after Generative Pre-trained Transformer (GPT)-assisted diagnostic support
Prazo: During the index emergency department visit (average 6 hours)
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Diagnostic concordance between the physician's final emergency department diagnosis after Generative Pre-trained Transformer (GPT)-assisted multimodal diagnostic support and the blinded adjudicated reference diagnosis in participants assigned to the intervention group.
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During the index emergency department visit (average 6 hours)
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Time from emergency department presentation to final diagnosis
Prazo: During the index emergency department visit (average 6 hours)
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Time required from emergency department presentation until establishment of the physician's final emergency department diagnosis.
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During the index emergency department visit (average 6 hours)
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Diagnostic reclassification after Generative Pre-trained Transformer (GPT)-assisted evaluation
Prazo: During the index emergency department visit (average 6 hours)
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Frequency of changes between the physician's initial working diagnosis and the final emergency department diagnosis after review of Generative Pre-trained Transformer (GPT)-generated diagnostic recommendations.
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During the index emergency department visit (average 6 hours)
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Physician diagnostic confidence
Prazo: During the index emergency department visit (average 6 hours)
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Physician-reported diagnostic confidence recorded before and after Generative Pre-trained Transformer (GPT)-assisted diagnostic support using the prespecified study assessment scale.
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During the index emergency department visit (average 6 hours)
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Physician acceptance of Generative Pre-trained Transformer (GPT)-generated diagnostic recommendations
Prazo: During the index emergency department visit (average 6 hours)
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Frequency of physician acceptance, modification, or rejection of Generative Pre-trained Transformer (GPT)-generated diagnostic recommendations in the intervention group.
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During the index emergency department visit (average 6 hours)
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Emergency department disposition accuracy
Prazo: Up to hospital discharge (average 3 days)
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Accuracy of emergency department disposition decisions, including discharge, hospital admission, or intensive care unit admission, compared with the adjudicated reference diagnosis.
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Up to hospital discharge (average 3 days)
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Emergency department length of stay
Prazo: Up to hospital discharge (average 3 days)
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Length of stay in the emergency department measured from patient presentation until emergency department discharge or hospital admission.
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Up to hospital discharge (average 3 days)
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Hospital length of stay
Prazo: Up to hospital discharge (average 3 days)
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Total duration of hospitalization from admission until hospital discharge.
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Up to hospital discharge (average 3 days)
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In-hospital mortality
Prazo: Up to hospital discharge (average 3 days)
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All-cause mortality occurring during the index hospitalization.
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Up to hospital discharge (average 3 days)
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30-day all-cause mortality
Prazo: 30 days
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All-cause mortality occurring within 30 days after the index emergency department visit.
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30 days
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30-day emergency department revisit
Prazo: 30 days
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Revisit to any emergency department for any cause within 30 days after the index emergency department visit.
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30 days
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30-day hospital readmission
Prazo: 30 days
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Hospital readmission for any cause within 30 days after discharge from the index hospitalization.
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30 days
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Topol EJ. High-performance medicine: the convergence of human and artificial intelligence. Nat Med. 2019 Jan;25(1):44-56. doi: 10.1038/s41591-018-0300-7. Epub 2019 Jan 7.
- Lopez-Puerta JM, Fernandez-Marin MR, Martin Benlloch JA, Lorente R. Spinal osteoid osteoma recurring as an aggressive osteoblastoma. Neurocirugia (Engl Ed). 2020 May-Jun;31(3):146-150. doi: 10.1016/j.neucir.2019.06.002. Epub 2019 Sep 2. English, Spanish.
- ANCA-associated vasculitis. Nat Rev Dis Primers. 2020 Aug 27;6(1):72. doi: 10.1038/s41572-020-0212-y. No abstract available.
- Kim TH, Kim CH, Choi SG. Radiation-induced angiosarcoma (RIAS) of the maxilla: a case report. J Korean Assoc Oral Maxillofac Surg. 2020 Aug 31;46(4):288-291. doi: 10.5125/jkaoms.2020.46.4.288.
- Li R, Chen X, Wang Y. Adverse events analysis of Relugolix (Orgovyx(R)) for prostate cancer based on the FDA Adverse Event Reporting System (FAERS). PLoS One. 2024 Oct 22;19(10):e0312481. doi: 10.1371/journal.pone.0312481. eCollection 2024.
- Asravor RK. Uncovering the forgotten story of the impact of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome on economic growth in Ghana: A gender analysis. Int J Health Plann Manage. 2023 Sep;38(5):1495-1509. doi: 10.1002/hpm.3675. Epub 2023 Jun 23.
- Shakiba M, Nazemipour M, Mansournia N, Mansournia MA. Protective effect of intensive glucose lowering therapy on all-cause mortality, adjusted for treatment switching using G-estimation method, the ACCORD trial. Sci Rep. 2023 Apr 10;13(1):5833. doi: 10.1038/s41598-023-32855-3.
- Hsu HW, Chiu MC, Shoemaker D, Yang CS. Viral infections in fire ants lead to reduced foraging activity and dietary changes. Sci Rep. 2018 Sep 10;8(1):13498. doi: 10.1038/s41598-018-31969-3.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de janeiro de 2027
Conclusão Primária (Estimado)
31 de dezembro de 2028
Conclusão do estudo (Estimado)
31 de dezembro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
18 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de julho de 2026
Primeira postagem (Real)
27 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ER-VISION-AI study
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano IPD
The investigators have not yet determined whether de-identified individual participant data (IPD), including the analyzable dataset and supporting documentation, will be shared with researchers outside the study team.
A final decision will be made after completion of the study, taking into consideration institutional policies, participant privacy, ethical requirements, and applicable regulations.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .