Early Thrombolysis Guided by AI-Assisted App in Patients With STEMI

Официальное название

Early Pre-hospital Thrombolysis Guided by Artificial Intelligence Assisted Mobile Application in Patients With ST-elevation Myocardial Infarction: A Multi-center Cluster Randomized Controlled Trial

Обзор

The aim of the study is to elucidate whether guiding by a novel artificial intelligence assisted mobile application can improve the clinical outcomes of patients in whom "guide wire passing through the lesion" could not be achieved within 120 min after diagnosis of STEMI, compared to conventional treatment strategies. With concerns of the inadequate use of thrombolysis in patients with STEMI in China, this study applies a new artificial intelligence assisted mobile application to guide the process of thrombolysis combined with PCI treatment, in order to accomplish the rapid coordination and cooperation of the whole medical network during re-perfusion treatment in different regions and different medical institutions in China, increases the proportion of early thrombolysis in pre-hospital setting, shortens the time from STEMI onset to reperfusion, and provides a reliable, effective and replicable new strategy for promoting and optimizing early reperfusion.

Вмешательства

• Другое A novel artificial intelligence assisted mobile application
  A novel artificial intelligence assisted mobile application will be used in the experimental group to guide entire reperfusion process in patients with STEMI. The functions of the application include patient screening, education and training, route planning for patient transfer, time management, and quality control, etc.The thrombolytic drug used in this study is tenecteplase (manufacturer: CSPC Pharmaceutical Group Limited, China ).

Первичные конечные точки

• Incidence of major adverse events (MAEs) at 1 year [Срок оценки: Day 365]

Вторичные конечные точки (7)

• Total ischemic time before reperfusion [Срок оценки: Day 30]
• Total reperfusion rate during therapeutic time window [Срок оценки: Hour 48]
• The proportion of ECG ST segment resolution（STR） ≥ 70% after thrombolysis or emergency PCI [Срок оценки: Hour 48]
• Proportion of TIMI blood flow grade 3 before emergency PCI [Срок оценки: Hour 48]
• Proportion of TIMI blood flow grade 3 after emergency PCI [Срок оценки: Hour 48]
• Incidence of 30-day MAEs [Срок оценки: Day 30]
• Incidence of major adverse cardiac events (MACE) at 1 year [Срок оценки: Day 365]

Критерии участия

Критерии включения

• (the following inclusion conditions shall be met at the same time):

• age: ≥ 18 years and ≤ 80 years;
• Chest pain lasted for more than 30 min, and the onset time of chest pain was ≤ 12 hours;
• ECG: ST segment elevation after J-point in 2 or more adjacent leads: limb leads ≥ 0.1 mv or chest leads ≥ 0.2 mv;
• it is expected that "guide wire passing through the lesion" could not be achieved within 120 min after the diagnosis of STEMI;
• Signed informed consent .

Критерии исключения

• (1) Cardiac rupture; (2) Complete left bundle branch block (LBBB) or ventricular pacing; (3) There are contraindications to thrombolysis; (4) Have serious comorbidities; (5) Have complex heart disease; (6) There are situations that are not suitable for clinical trials.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• No. 83, Wenhua Road, Shenhe District, Shenyang City — Шэньян

Идентификаторы

NCT: NCT07160491 · EARLY-OPEN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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