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Recruiting NCT07160491

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

No phase Interventional STEMI - ST Elevation Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A novel artificial intelligence assisted mobile application.
Who it may be relevant to
Registry conditions: STEMI - ST Elevation Myocardial Infarction. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • 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 ).

Primary outcome measures

  • Incidence of major adverse events (MAEs) at 1 year [Time frame: Day 365]
Secondary outcome measures (7)
  • Total ischemic time before reperfusion [Time frame: Day 30]
  • Total reperfusion rate during therapeutic time window [Time frame: Hour 48]
  • The proportion of ECG ST segment resolution（STR） ≥ 70% after thrombolysis or emergency PCI [Time frame: Hour 48]
  • Proportion of TIMI blood flow grade 3 before emergency PCI [Time frame: Hour 48]
  • Proportion of TIMI blood flow grade 3 after emergency PCI [Time frame: Hour 48]
  • Incidence of 30-day MAEs [Time frame: Day 30]
  • Incidence of major adverse cardiac events (MACE) at 1 year [Time frame: Day 365]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • No. 83, Wenhua Road, Shenhe District, Shenyang City — Shenyang

Identifiers

NCT: NCT07160491 · EARLY-OPEN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗