STEMI - ST Elevation Myocardial Infarction
Conditions
Keywords
Thrombolysis, appliaction, myocardial infarction, cluster randomized trial
Brief summary
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.
Interventions
OTHERA 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 ).
Sponsors
Shenyang Northern Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multi-center, cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* (the following inclusion conditions shall be met at the same time): 1. age: ≥ 18 years and ≤ 80 years; 2. Chest pain lasted for more than 30 min, and the onset time of chest pain was ≤ 12 hours; 3. ECG: ST segment elevation after J-point in 2 or more adjacent leads: limb leads ≥ 0.1 mv or chest leads ≥ 0.2 mv; 4. it is expected that guide wire passing through the lesion could not be achieved within 120 min after the diagnosis of STEMI; 5. Signed informed consent .
Exclusion criteria
* (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse events (MAEs) at 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Total ischemic time before reperfusion | Day 30 | — |
| Incidence of 30-day MAEs | Day 30 | MAE is a composite endpoint that includes all-cause mortality, stroke, cardiogenic shock, rehospitalization for ischemic heart failure, or reinfarction. |
| Incidence of major adverse cardiac events (MACE) at 1 year | Day 365 | MACE is a composite endpoint including cardiac death, reinfarction, clinically-driven revascularization, ischemic cardiomyopathy, or myocardial ischemia-driven rehospitalization |
| Proportion of TIMI blood flow grade 3 after emergency PCI | Hour 48 | — |
Countries
China
Contacts
Primary ContactKai Xu, MD,PhD
Outcome results
None listed