RecruitingNot ApplicableNCT07160491

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

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


Sponsor

Shenyang Northern Hospital

Enrollment

3,356 participants

Start Date

Sep 8, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • (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 .

Exclusion Criteria1

  • (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.

Interested in this trial?

Get notified about updates and connect with the research team.

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 ).


Locations(1)

No. 83, Wenhua Road, Shenhe District, Shenyang City

Shenyang, Liaoning, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07160491


Related Trials