此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Machine Learning for Diagnosis of Occlusive MI in LBBB Patients (AI-LBBB)

2026年5月22日 更新者:Ahmet Gumus、Konya City Hospital

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.

研究概览

研究类型

观察性的

注册 (估计的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Karatay
      • Konya、Karatay、土耳其(türkiye)、42100
        • 招聘中
        • Konya City Hospital
        • 接触:
          • Ahmet Gumus, MD, Emergency Medicine Residen
          • 电话号码:+905547957490
          • 邮箱:ahmetgms88@gmail.com

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population consists of adult patients who present to the emergency department of a major tertiary care referral and research hospital (Konya City Hospital) with clinical symptoms highly suggestive of acute myocardial ischemia (such as chest pain or dyspnea) and whose initial 12-lead electrocardiogram (ECG) demonstrates a Left Bundle Branch Block (LBBB). This population represents a real-world, unselected cohort of emergency patients requiring immediate diagnostic workup and potential emergent or urgent invasive coronary angiography for suspected acute coronary occlusion.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Diagnostic Performance for Occlusive Acute Myocardial Infarction
大体时间: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).

次要结果测量

结果测量
措施说明
大体时间
Title: Differentiation Performance Between Type 1 MI and Type 2 MI
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年5月22日

首先提交符合 QC 标准的

2026年5月22日

首次发布 (实际的)

2026年6月2日

研究记录更新

最后更新发布 (实际的)

2026年6月2日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅