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

NCT ID: NCT07160491

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-08

Study Completion Date

2029-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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STEMI - ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-center, cluster randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

A novel artificial intelligence assisted mobile application

Intervention Type 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 ).

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 ).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenyang Northern Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han Yaling

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yaling Han, MD,PhD

Role: STUDY_CHAIR

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

Locations

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

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Xu, MD,PhD

Role: CONTACT

+8615309880917

Facility Contacts

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Kai Xu, MD,PhD

Role: primary

+8615309880917

Other Identifiers

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EARLY-OPEN

Identifier Type: -

Identifier Source: org_study_id

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