Early Thrombolysis Guided by AI-Assisted App in Patients With STEMI (EARLY-OPEN)

Shenyang Northern Hospital

Status: Enrolling

Conditions: STEMI - ST Elevation Myocardial Infarction

Treatments: Other: A novel artificial intelligence assisted mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT07160491

EARLY-OPEN

Details and patient eligibility

About

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.

Enrollment: 3,356 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,356 participants in 2 patient groups

Comprehensive promotion group

Experimental group

Description:

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.

Treatment:

Other: A novel artificial intelligence assisted mobile application

Control group

No Intervention group

Description:

Patients in the control group will be tranferred and managed according to the existing model