Early Thrombolysis Guided by AI-Assisted App in Patients With STEMI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShenyang Northern Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
(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.
Trial design
Design model
Parallel
Treatments tested in this trial
A novel artificial intelligence assisted mobile application
Other interventionA 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 ).
Treatment groups
3,356 Participants
are divided into 2 treatment groupsGroup A: Comprehensive promotion groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of major adverse events (MAEs) at 1 year
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.
Time frame
Day 365Secondary outcomes
1
Total ischemic time before reperfusion
Time frame
Day 302
Total reperfusion rate during therapeutic time window
Time frame
Hour 483
The proportion of ECG ST segment resolution（STR） ≥ 70% after thrombolysis or emergency PCI
Time frame
Hour 484
Proportion of TIMI blood flow grade 3 before emergency PCI
Time frame
Hour 48Sponsors and contacts
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Source ClinicalTrials.gov