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NCT Number: NCT07160491

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

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.

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Key information

Conditions

STEMI - ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shenyang, Liaoning, China

Location status: Recruiting

Location contact

Kai Xu, MD,PhD

CONTACT

[email protected]

+8615309880917

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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 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.

Treatment and study plan

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 ).

Primary outcomes

  1. Incidence of major adverse events (MAEs) at 1 year

    Time frame: Day 365

    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.

Secondary outcomes

  1. Total ischemic time before reperfusion

    Time frame: Day 30

  2. Total reperfusion rate during therapeutic time window

    Time frame: Hour 48

  3. The proportion of ECG ST segment resolution（STR） ≥ 70% after thrombolysis or emergency PCI

    Time frame: Hour 48

  4. Proportion of TIMI blood flow grade 3 before emergency PCI

    Time frame: Hour 48

  5. Proportion of TIMI blood flow grade 3 after emergency PCI

    Time frame: Hour 48

  6. Incidence of 30-day MAEs

    Time frame: Day 30

    MAE is a composite endpoint that includes all-cause mortality, stroke, cardiogenic shock, rehospitalization for ischemic heart failure, or reinfarction.

  7. Incidence of major adverse cardiac events (MACE) at 1 year

    Time frame: Day 365

    MACE is a composite endpoint including cardiac death, reinfarction, clinically-driven revascularization, ischemic cardiomyopathy, or myocardial ischemia-driven rehospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Xu, MD,PhD

CONTACT

[email protected]

+8615309880917

Sponsors and collaborators

Lead sponsor

Shenyang Northern Hospital

Other

Registry information

Official study title

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

Acronym: EARLY-OPEN

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 8, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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