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

NCT07160491 | Recruiting DMC

• 1 other identifier: EARLY-OPEN
• Study Type: interventional
• Target: 3,356
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

Thrombolysis; appliaction; myocardial infarction; cluster randomized trial

Outcome Measures

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.

  Day 365

Secondary Outcomes (7)

• 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

Study Arms (2)

Comprehensive promotion group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

A novel artificial intelligence assisted mobile application OTHER

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 ).

Comprehensive promotion group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• (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.

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

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

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Yaling Han, MD,PhD

  Northern Theater Command General Hospital of the People's Liberation Army

  STUDY CHAIR

Central Study Contacts

Kai Xu, MD,PhD

CONTACT

+8615309880917; xukai2001@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Multi-center, cluster randomized controlled trial

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 8, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)