STEMI - ST Elevation Myocardial InfarctionEARLY-OPENNCT07160491
Early Thrombolysis Guided by AI-Assisted App in Patients With STEMI
A study testing A novel artificial intelligence assisted mobile application in people with STEMI - ST Elevation Myocardial Infarction, run by Shenyang Northern Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- A novel artificial intelligence assisted mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,356 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2025to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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 .
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
No. 83, Wenhua Road, Shenhe District, Shenyang City
Shenyang, Liaoning
Kai Xu, MD,PhD, +8615309880917, xukai2001@sina.com
About this study
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
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.
- Being tested
- A novel artificial intelligence assisted mobile application
- Keywords
- Thrombolysis, appliaction, myocardial infarction, cluster randomized trial
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A novel artificial intelligence assisted mobile applicationOther
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 ).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 365
Secondary outcomes (7)
Total ischemic time before reperfusion
Measured: Day 30
Total reperfusion rate during therapeutic time window
Measured: Hour 48
The proportion of ECG ST segment resolution（STR） ≥ 70% after thrombolysis or emergency PCI
Measured: Hour 48
Proportion of TIMI blood flow grade 3 before emergency PCI
Measured: Hour 48
Proportion of TIMI blood flow grade 3 after emergency PCI
Measured: Hour 48
Incidence of 30-day MAEs
MAE is a composite endpoint that includes all-cause mortality, stroke, cardiogenic shock, rehospitalization for ischemic heart failure, or reinfarction.
Measured: Day 30
Incidence of major adverse cardiac events (MACE) at 1 year
MACE is a composite endpoint including cardiac death, reinfarction, clinically-driven revascularization, ischemic cardiomyopathy, or myocardial ischemia-driven rehospitalization
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start8 Sep 2025
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 3,356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
- Investigators
- Yaling Han, MD,PhD, Study chair, Northern Theater Command General Hospital of the People's Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160491
- Sponsor's protocol ID
- EARLY-OPEN
- Acronym
- EARLY-OPEN
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07160491
- Acronym / sponsor ID
- EARLY-OPEN / EARLY-OPEN
- Keywords
- Thrombolysis, appliaction, myocardial infarction, cluster randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,356 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center, cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Comprehensive promotion group | Experimental | Other: A novel artificial intelligence assisted mobile applicationA 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. |
| Control group | No intervention | –Patients in the control group will be tranferred and managed according to the existing model |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (the following inclusion conditions shall be met at the same time):
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A novel artificial intelligence assisted mobile applicationA 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 ). | Other | Comprehensive promotion group |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yaling Han, MD,PhD study chair
Northern Theater Command General Hospital of the People's Liberation Army
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A novel artificial intelligence assisted mobile application in people with STEMI - ST Elevation Myocardial Infarction, run by Shenyang Northern Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Xu, MD,PhD (+8615309880917, xukai2001@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse events (MAEs) at 1 year (time frame: Day 365). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.