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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,356
- 试验地点
- 1
- 主要终点
- Incidence of major adverse events (MAEs) at 1 year
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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 .
排除标准
- •(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.
结局指标
主要结局
Incidence of major adverse events (MAEs) at 1 year
时间窗: Day 365
Incidence of major adverse events (MAEs) at 1 year. MAE is a composite endpoint that includes all-cause mortality, stroke, cardiogenic shock, rehospitalization for ischemic heart failure, or reinfarction.
Incidence of major adverse events (MAEs) at 1 year
时间窗: Day 365
Incidence of major adverse events (MAEs) at 1 year. MAE is a composite endpoint that includes all-cause mortality, stroke, cardiogenic shock, rehospitalization for ischemic heart failure, or reinfarction.
次要结局
- Incidence of major adverse cardiac events (MACE) at 1 year(Day 365)
- Total ischemic time before reperfusion(Day 30)
- Total reperfusion rate during therapeutic time window(Hour 48)
- The proportion of ECG ST segment resolution（STR） ≥ 70% after thrombolysis or emergency PCI(Hour 48)
- Proportion of TIMI blood flow grade 3 before emergency PCI(Hour 48)
- Proportion of TIMI blood flow grade 3 after emergency PCI(Hour 48)
- Incidence of 30-day MAEs(Day 30)
- Incidence of major adverse cardiac events (MACE) at 1 year(Day 365)
研究者
Han Yaling
MD, PhD
Shenyang Northern Hospital