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

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

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.

Study Overview

• Status: Recruiting
• Conditions: STEMI - ST Elevation Myocardial Infarction
• Intervention / Treatment: Other: A novel artificial intelligence assisted mobile application

• Study Type: Interventional
• Enrollment (Estimated): 3356
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kai Xu, MD,PhD; Phone Number: +8615309880917; Email: xukai2001@sina.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • No. 83, Wenhua Road, Shenhe District, Shenyang City
      • Contact: Kai Xu, MD,PhD; Phone Number: +8615309880917; Email: xukai2001@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comprehensive promotion group; 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.	Other: A 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 ).
No Intervention: Control group; Patients in the control group will be tranferred and managed according to the existing model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 365

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	MAE is a composite endpoint that includes all-cause mortality, stroke, cardiogenic shock, rehospitalization for ischemic heart failure, or reinfarction.	Day 30
Incidence of major adverse cardiac events (MACE) at 1 year	MACE is a composite endpoint including cardiac death, reinfarction, clinically-driven revascularization, ischemic cardiomyopathy, or myocardial ischemia-driven rehospitalization	Day 365

Collaborators and Investigators

• Sponsor: Shenyang Northern Hospital
• Investigators: Study Chair: Yaling Han, MD,PhD, Northern Theater Command General Hospital of the People's Liberation Army

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: August 21, 2025
• First Submitted That Met QC Criteria: August 29, 2025
• First Posted (Estimated): September 8, 2025

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 14, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: myocardial infarction; Thrombolysis; cluster randomized trial; appliaction
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Myocardial Infarction
• Other Study ID Numbers: EARLY-OPEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No