AI-guided early thrombolysis for people with STEMI
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
This trial tests whether an AI-assisted mobile app can help clinicians give earlier thrombolysis (plus planned PCI) for adults with STEMI who are unlikely to have the lesion opened within 120 minutes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3356 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shenyang Northern Hospital Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT07160491 on ClinicalTrials.gov |
What this trial studies
This is a cluster-randomized interventional program comparing an AI-assisted mobile application to usual care across participating hospitals and regions in China. The app is used to guide timely thrombolysis combined with coordination for PCI in adults presenting with ST-elevation myocardial infarction within 12 hours of symptom onset. The trial enrolls patients for whom guide-wire passage through the culprit lesion is not expected within 120 minutes of diagnosis and aims to increase pre-hospital and early in-hospital thrombolysis. Outcomes include time from symptom onset to reperfusion and clinical endpoints related to myocardial salvage and complications.
Who should consider this trial
Good fit: Adults aged 18–80 with STEMI within 12 hours of symptom onset, chest pain >30 minutes, ST elevation in two or more adjacent leads, and an anticipated inability to achieve guide-wire crossing within 120 minutes who can provide informed consent.
Not a fit: Patients with contraindications to thrombolysis, cardiac rupture, complete LBBB or ventricular pacing, serious comorbidities, complex heart disease, or other conditions making them unsuitable for trial participation are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could increase early thrombolysis rates, shorten time to reperfusion, and improve clinical outcomes for patients who face PCI delays.
How similar studies have performed: Prior clinical trials support early thrombolysis when timely PCI is not possible, but using an AI-assisted mobile app to coordinate and guide thrombolysis is a novel approach that has not been widely tested in large randomized programs.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shenyang, Liaoning
- No. 83, Wenhua Road, Shenhe District, Shenyang City — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Kai Xu, MD,PhD
- Email: xukai2001@sina.com
- Phone: +8615309880917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.