- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07843004
Capitalizing on AI to CapTure Undiagnosed Structural Heart Disease (CACTUS)
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
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michelle S Castillo, MS
- Número de teléfono: 7322777644
- Correo electrónico: mc5067@cumc.columbia.edu
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10032
- Reclutamiento
- Columbia University Irving Medical Center / NewYork-Presbyterian
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Contacto:
- Michelle Castillo, MS
- Número de teléfono: 732-277-7644
- Correo electrónico: mc5067@cumc.columbia.edu
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Investigador principal:
- Pierre Elias, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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. |
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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:
|
¿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
Patrocinador
Investigadores
- Investigador principal: Pierre Elias, MD, Columbia University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AAAU9699
- 1R01HL177055-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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