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Capitalizing on AI to CapTure Undiagnosed Structural Heart Disease (CACTUS)

21 de septiembre de 2026 actualizado por: Pierre Elias

Doctors are testing a new tool called EchoNext to see if it can help find heart problems earlier. EchoNext looks at the heart's electrical test, called an ECG, and uses artificial intelligence (AI) to check for signs of structural heart disease (SHD). SHD includes conditions like weak heart pumping, heart valve problems, or extra thickening of the heart muscle. These problems are common but often go undiagnosed until they cause serious issues like heart failure or stroke.

The main questions this study will answer are:

Can EchoNext alerts help emergency doctors find hidden heart problems sooner?

Does this lead to more follow-up heart tests, like an echocardiogram (heart ultrasound)?

What this means for patients: If a person has an ECG in the Emergency Department, the EchoNext tool may be used to check their heart. If the tool finds something unusual, their doctor may receive an alert and may then recommend further heart tests or follow-up care.

This study will help researchers learn if using EchoNext improves early diagnosis and treatment of heart disease.

Descripción general del estudio

Descripción detallada

Structural heart disease (SHD) is a major cause of illness and death, especially in older adults. SHD includes conditions such as valvular heart disease (e.g., aortic stenosis, mitral regurgitation), left or right ventricular dysfunction, left ventricular hypertrophy, pulmonary artery hypertension, and pericardial effusions. These conditions are often underdiagnosed, and delayed recognition can lead to complications such as heart failure, stroke, and cardiomyopathy. Early detection and treatment can improve outcomes, but current approaches often miss patients in the early stages of disease.

EchoNext is an artificial intelligence model trained on over 400,000 ECG-echocardiogram pairs. It analyzes the standard 12-lead ECG to predict the presence of structural heart disease, as defined by echocardiographic findings. The model has demonstrated strong diagnostic performance, with an area under the receiver operating characteristic (AUROC) curve of 0.86 across diverse populations.

The purpose of this trial is to evaluate whether deploying EchoNext into the Emergency Department (ED) electronic health record (EHR) as a clinical decision support alert can increase the detection of undiagnosed SHD. The ED setting is ideal because: (1) ECGs are widely obtained for many presenting complaints, (2) abnormal ECG findings related to SHD are often overlooked in the acute setting, and (3) EDs provide access to disadvantaged populations and a unique opportunity to deliver population-level interventions.

In this study, ECGs obtained in the ED will be analyzed in real time by the EchoNext model. If the model predicts moderate or severe SHD, an EHR alert will be displayed to the treating provider (attending physician, fellow, resident, physician assistant, or nurse practitioner). The alert will inform providers of the potential for underlying SHD and recommend consideration of follow-up echocardiography or specialty referral. Outcomes will include rates of new SHD diagnoses confirmed by echocardiography, follow-up testing and referrals, and downstream patient outcomes.

The Community Tele-Paramedicine (CTP) program, an established post-discharge care initiative at NewYork-Presbyterian, will also serve as a follow-up resource for patients identified in the ED. CTP combines home visits by community paramedics, telehealth visits by emergency physicians, and nurse care management to coordinate outpatient testing and follow-up care. Integration with CTP will facilitate timely echocardiography and referral for patients flagged by EchoNext, particularly for high-risk or underserved populations.

This trial will determine whether AI-driven ECG interpretation can improve early detection of SHD and lead to better patient outcomes compared to standard care.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

4000

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • New York
      • New York, New York, Estados Unidos, 10032
        • Reclutamiento
        • Columbia University Irving Medical Center / NewYork-Presbyterian
        • Contacto:
        • Investigador principal:
          • Pierre Elias, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 40 years of age or older
  • Received an ECG upon presentation to the Emergency Department

Exclusion Criteria:

  • Had an echocardiogram within the prior 2 years.
  • Has a history of structural heart disease.
  • Not able to receive follow-up based on Community Tele-Paramedicine care manager review.
  • Quality of life will not improve over the next five years.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Poner en pantalla
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Standard Treatment - No EHR Alert

Emergency department providers will not be alerted in the electronic health record (EHR) if a patient's electrocardiogram (ECG) ordered in the ED is identified by the EchoNext algorithm as suggesting structural heart disease (SHD) and potentially benefit from an echocardiogram.

Experimental: Intervention - EHR Alert & Community Tele-paramedicine

Emergency department providers will be alerted in the electronic health record (EHR) if a patient's electrocardiogram (ECG) ordered in the ED is identified by the EchoNext algorithm as suggesting structural heart disease (SHD) and potentially benefit from an echocardiogram. These patients will also be referred to Community Tele-paramedicine for follow-up for potential echocardiogram.

EKG Algorithm to identify structural heart disease

Otros nombres:
  • EchoNext

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of new diagnoses of Structural Heart Disease (SHD)
Periodo de tiempo: 180 days post index ED visit

Number of patients with a new diagnosis of structural heart disease (SHD), including moderate or greater valvular disease, left or right ventricular systolic dysfunction, left ventricular hypertrophy, pulmonary artery hypertension, or moderate/large pericardial effusions, confirmed by echocardiography or other clinical evaluation.

180 days post index ED visit

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rate of echocardiography ordering
Periodo de tiempo: 180 days post index ED visit

Proportion of patients who received an echocardiogram following the index ED visit.

180 days post index ED visit
New Medical Treatments for SHD
Periodo de tiempo: 180 days post index ED visit

Number of patients initiating new cardiovascular medications (e.g., antihypertensives, diuretics) specifically for treatment of structural heart disease.

180 days post index ED visit
New Surgical or Procedural Interventions for SHD
Periodo de tiempo: 180 days post-index ED visit

Number of patients undergoing procedural interventions for SHD, including valve repair/replacement, cardiac surgery, drainage of pericardial effusion, or implanted defibrillator placement.

180 days post-index ED visit
Long-Term Medical Treatments for SHD
Periodo de tiempo: 1 year post-index ED visit

Number of patients who initiated new cardiovascular medications (e.g., antihypertensives, diuretics) for treatment of structural heart disease within 1 year.

1 year post-index ED visit

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Pierre Elias, MD, Columbia University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de septiembre de 2026

Finalización primaria (Estimado)

1 de junio de 2027

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

21 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de septiembre de 2026

Publicado por primera vez (Actual)

25 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data (IPD) from this study will not be shared. The data contain protected health information (PHI) from electronic health records (EHR) and are linked to specific patients and providers. Sharing this information could risk patient privacy and confidentiality, even with de-identification. Additionally, the data are collected under institutional policies and HIPAA regulations that restrict external access.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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