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Идёт набор NCT07620119

Machine Learning for Diagnosis of Occlusive MI in LBBB Patients

— Наблюдательное Acute Myocardial Infarction (AMI) Left Bundle Branch Block Coronary Occlusion/Thrombosis Chest Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Digital 12-Lead ECG Analysis and Invasive Coronary Angiography.
Кому может быть актуально
Состояния в реестре: Acute Myocardial Infarction (AMI), Left Bundle Branch Block, Coronary Occlusion/Thrombosis, Chest Pain. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Development of a Machine Learning Model for the Diagnosis of Occlusive Myocardial Infarction in the Setting of Left Bundle Branch Block

Обзор

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.

Вмешательства

  • Другое Digital 12-Lead ECG Analysis and Invasive Coronary Angiography
    Standard 12-lead digital electrocardiogram (ECG) data recorded during the emergency department index visit will be analyzed using a developed machine learning model. The model's predictions will be compared against the results of standard invasive coronary angiography (the gold standard reference method) performed as part of routine clinical care.

Первичные конечные точки

  • Diagnostic Performance for Occlusive Acute Myocardial Infarction [Срок оценки: Within the emergency department index visit (typically within 24 hours of presentation).]
Вторичные конечные точки (2)
  • Title: Differentiation Performance Between Type 1 MI and Type 2 MI [Срок оценки: Within the hospital stay (up to 7 days).]
  • Projected Reduction Rate of Unnecessary Angiographies [Срок оценки: Calculated at the study completion]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Konya City Hospital — Konya

Идентификаторы

NCT: NCT07620119 · 2026/133

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗