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Universidade Chinesa de Hong KongArtificial Intelligence in Aortic Regurgitation 540 Randomizado
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07486271 é um estudo intervencionista para Aortic Regurgitation Disease. Seu status atual é: em recrutamento. O estudo começou em 1 de dezembro de 2025 e pretende incluir 540 participantes. Coordenado por a Universidade Chinesa de Hong Kong e deve ser concluído em 31 de março de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 20 de março de 2026.
Resumo
This research project aims to develop and validate a tool that uses artificial intelligence (AI) to automatically detect and quantify aortic regurgitation (AR). The clinical efficacy of this tool will be established by comparing it to manual diagnostic methods in a multicenter randomized controlled trial. By leveraging deep learning (DL) techniques, the AI system will automate aortic regurgitation (AR) detection, mea...Mostrar mais
Título oficial
Artificial Intelligence in Aortic Regurgitation: A Multicenter Randomised Controlled Trial
Condições médicas
Aortic Regurgitation DiseaseOutros IDs do estudo
- 2024.689-T
Número NCT
Data de início (real)
2025-12-01
Última atualização postada
2026-03-20
Data de conclusão (estimada)
2028-03-31
Inscrição (estimada)
540
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Palavras-chave
Aortic Regurgitation
Artificial Intelligence
Echocardiography
Automated Diagnosis
Clinical Efficacy
Artificial Intelligence
Echocardiography
Automated Diagnosis
Clinical Efficacy
Propósito principal
Diagnóstico
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Duplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Comparador ativoAI-Assisted Group AR severity will be assessed using an AI tool that evaluates grading and key echocardiographic parameters (e.g., EROA, VC, PISA, jet width, and RegVol), along with the time required for assessments. | AI-Assisted Group Participants in this group will undergo aortic regurgitation assessment using an advanced artificial intelligence tool. |
OutroManual Measurement Group AR severity will be assessed manually by trained sonographers following standard protocols. Cardiologists (ASE level III or equivalent), blinded to patient history and group assignment, will review both AI-generated and manual outputs to make final diagnoses and treatment decisions based solely on the initial assessments. | Manual measurement group Participants in this group will receive a traditional diagnostic assessment for aortic regurgitation, performed by trained sonographers following standard protocols. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Study Outcomes | To compare the accuracy of the AI group and the manual group in distinguishing severe from non-severe AR, using expert cardiologists' (ASE level III or equivalent) assessments as the reference standard. | This will be recorded from baseline to study completion (20 months) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Comparing Accuracy in Differentiating AR Severity Levels | To compare the accuracy of the AI group and the manual group in differentiating trace, mild, moderate, and severe aortic regurgitation, using cardiologists' assessments as the reference standard. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Effective Regurgitant Orifice Area (EROA) | The Effective Regurgitant Orifice Area (EROA) assesses the size of a valve opening that leads to backward blood flow in the heart. It is an important metric for evaluating valvular regurgitation and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Vena Contracta (VC) | The Vena Contracta (VC) is an important measurement in echocardiography used to evaluate how severe mitral regurgitation is and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Proximal Isovelocity Surface Area (PISA) | Proximal Isovelocity Surface Area (PISA) is a method used in echocardiography to evaluate mitral regurgitation and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in jet width | The jet width is a critical measurement used to assess the severity of aortic regurgitation and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Regurgitant Volume (RegVol) | Regurgitant Volume assesses how much blood leaks back into the left atrium during mitral regurgitation and will be measured using Doppler echocardiography. | This will be recorded from baseline to study completion (20 months) |
Comparing Assessment Completion Time | To compare the time taken by the AI group, the manual group, and the cardiologists to complete their assessments. | The time taken for each method to reach a diagnosis will be recorded from baseline to study completion (20 months) |
Tracking 1-Year Outcomes | To track 1-year all-cause mortality and heart failure hospitalizations (HFH), comparing outcomes for patients with severe aortic regurgitation identified by the AI and manual groups, separately. | Participants will be followed up at 6 and 12 months to monitor outcomes, including 1-year all-cause mortality and HFH. |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- Confirmed AR diagnosis via TTE and Doppler imaging per guidelines.
- Age ≥ 18 years.
- Adequate acoustic window for AR quantification.
- Prior cardiac transplant or implanted cardiac devices.
- Poor image quality.
- Pregnancy or lactation.
Universidade Chinesa de Hong Kong474 estudos clínicos ativos para explorar- 🎓Semmelweis U...
Responsável pelo estudo
Dr Alex PW Lee, Investigador principal, Professor, Chinese University of Hong Kong
Contato central do estudo
Contato: Xueting Wang, (852) 3505 3840, [email protected]
1 Locais do estudo em 1 países
New Territories
Division of Cardiology, Department of Medicine and Therapeutics Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, New Territories, Sha Tin, Hong Kong
Xueting PW Wang, Professor, Contato, (852) 3505 3840, [email protected]
Em recrutamento