- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07620119
Machine Learning for Diagnosis of Occlusive MI in LBBB Patients (AI-LBBB)
Development of a Machine Learning Model for the Diagnosis of Occlusive Myocardial Infarction in the Setting of Left Bundle Branch Block
This study investigates a new way to diagnose severe heart attacks in patients who have a specific electrical heart pattern called a Left Bundle Branch Block (LBBB). When patients present to the emergency department with chest pain, doctors routinely perform an electrocardiogram (ECG) to check for a heart attack. However, the presence of an LBBB can alter the heart's electrical signals on the ECG, effectively masking or hiding the typical signs of an ongoing acute coronary occlusion (a completely blocked artery). This making it highly challenging for emergency physicians to make an accurate and rapid diagnosis.
The primary purpose of this prospective and observational research is to develop and evaluate an artificial intelligence/machine learning (ML) model that can analyze digital 12-lead ECG signals to accurately predict a true blocked coronary artery in patients with LBBB. The machine learning model will analyze raw digital ECG waveforms to detect subtle, microscopic patterns that might be missed by the human eye.
To confirm the accuracy of the model, its predictions will be compared directly with invasive coronary angiography results, which is the gold standard reference method used to visualize blocked vessels. Additionally, the study aims to evaluate if the model can differentiate between a true heart attack caused by a blocked artery (Type 1 MI) and other non-occlusive conditions that cause elevated heart enzymes (Type 2 MI). Ultimately, the investigators intend to determine whether integrating this machine learning tool into emergency care can safely reduce the rate of unnecessary emergency invasive procedures for patients who do not have a true coronary blockage.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Karatay
-
Konya, Karatay, Turquía (Türkiye), 42100
- Reclutamiento
- Konya City Hospital
-
Contacto:
- Ahmet Gumus, MD, Emergency Medicine Residen
- Número de teléfono: +905547957490
- Correo electrónico: ahmetgms88@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients aged 18 years and older who present to the emergency department. Patients presenting with acute ischemic chest pain or clinical ischemia-equivalent symptoms (such as acute dyspnea, unexplained diaphoresis, or syncope).
Patients with a confirmed Left Bundle Branch Block (LBBB) on their initial 12-lead electrocardiogram (ECG), which can be either newly developed or known/chronic.
Patients who undergo invasive coronary angiography during their index hospital admission.
Patients or their legally authorized representatives who provide written informed consent to participate in the study.
Exclusion Criteria:
- Patients under the age of 18. Pregnant or lactating women. Patients with poor-quality or uninterpretable digital ECG recordings due to severe artifact, missing leads, or technical errors.
Patients who develop cardiopulmonary arrest before an initial diagnostic 12-lead ECG can be obtained in the emergency department.
Patients transferred from another healthcare facility who have already undergone coronary angiography or revascularization.
Patients who decline to participate or refuse to provide written informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diagnostic Performance for Occlusive Acute Myocardial Infarction
Periodo de tiempo: Within the emergency department index visit (typically within 24 hours of presentation).
|
Evaluation of the developed machine learning model's diagnostic performance in predicting angiographically proven acute coronary occlusion (defined as TIMI 0-1 flow or equivalent true occlusion during catheterization).
The primary metrics to evaluate this outcome will include the Area Under the Receiver Operating Characteristic (ROC) Curve (AUC), Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV).
|
Within the emergency department index visit (typically within 24 hours of presentation).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Title: Differentiation Performance Between Type 1 MI and Type 2 MI
Periodo de tiempo: Within the hospital stay (up to 7 days).
|
Evaluation of the machine learning model's performance (measured by AUC, sensitivity, and specificity) to distinguish between acute coronary occlusion (Type 1 MI) and non-occlusive ischemic myocardial injury or supply-demand mismatch presenting with elevated cardiac troponin (Type 2 MI).
|
Within the hospital stay (up to 7 days).
|
|
Projected Reduction Rate of Unnecessary Angiographies
Periodo de tiempo: Calculated at the study completion
|
Simulation and post-hoc analysis to quantify the potential relative reduction in the rate of emergency invasive coronary angiographies among LBBB patients without true coronary occlusion by applying the model's diagnostic probability scores.
|
Calculated at the study completion
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Términos MeSH relevantes adicionales
- Enfermedad del sistema de conducción cardíaca
- Dolor
- Manifestaciones neurológicas
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades cardíacas
- Arritmias Cardiacas
- Infarto
- Necrosis
- Bloqueo cardíaco
- Embolia y Trombosis
- Enfermedad coronaria
- Isquemia miocardica
- Isquemia
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Trombosis
- Infarto de miocardio
- Bloque de rama de paquete
- Dolor de pecho
- Oclusión Coronaria
Otros números de identificación del estudio
- 2026/133
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.
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. .