Myocardial Infarction, AcuteNCT03317691
The ALERT-Pilot Study
An observational study of Myocardial Infarction, Acute and Artificial Intelligence, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
the algorithm of artificial intelligent to diagnose myocardial infarction through prior surgery Electrocardiogram was established. The accuracy of using artificial intelligent to diagnose acute ST-segment elevation myocardial infarction and judge criminal vascular was evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute, Artificial Intelligence, ECG Pattern
- What is being tested?
- electrocardiogram diagnosed by artificial intelligence
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2017to 1 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ST segment Elevation Myocardial Infarction patients' diagnosis was confired by coronary artery angiography. The prior surgery electrocardiogram need to be collected.
Who may be able to join
- age≥18 years old;
- the admitting doctor's diagnosis is ST-segment Elevation Myocardial Infarction.
Who cannot join
- the admitting diagnosis is non-ST-segment Elevation Myocardial Infarction.
- default data;
- pregnancy, mental disorder, kidney failure;
- except for criteria mention above, including some improper condition considered by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Yawei Xu, Professor of medicine, +86 02166306920, xuyaweicn@yahoo.com.cn
Yi Zhang, Professor, +86 02166306920, yizshcn@gmail.com
About this study
Official title: Automatic Diagnosis of ST-segment Elevated Myocardial Infarction by Artificial Intelligence-based Electrocardiographic System:The ALERT-Pilot Study
the algorithm of artificial intelligent to diagnose myocardial infarction through prior surgery Electrocardiogram was established. The accuracy of using artificial intelligent to diagnose acute ST-segment elevation myocardial infarction and judge criminal vascular was evaluated.
- Being tested
- electrocardiogram diagnosed by artificial intelligence
- Keywords
- myocardial infarction, artificial Intelligence, 12 lead electrocardiogram
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocardiogram diagnosed by artificial intelligenceDiagnostic test
According to coronary angiogram results, the accuracy of STEMI patients' electrocardiogram diagnosis by artificial intelligence was evaluated.
| Study group | Role | What they receive |
|---|---|---|
| ST segment Elevation Myocardial Infarction | ST segment Elevation Myocardial Infarction patients' diagnosis was confirmed by coronary artery angiography. The prior surgery electrocardiogram need to be collected. Receives: Diagnostic Test: electrocardiogram diagnosed by artificial intelligence |
What is being measured
The primary outcome is the main question the study is designed to answer.
the algorithm of artificial intelligent to diagnose myocardial infarction through prior surgery Electrocardiogram
All the electrocardiograms done before coronary arteriography were read by artificial intelligent. Then according to results of coronary angiogram, artificial intelligent can establish a algorithm of to diagnose myocardial infarction.
Measured: 24 hours
The accuracy of using artificial intelligent to diagnose acute ST-segment elevation myocardial infarction and judge criminal vascular
The accuracy of using artificial intelligent to diagnose acute ST-segment elevation myocardial infarction and judge criminal vascular was evaluated.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start20 Oct 2017
- Primary completion15 Oct 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction, AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317691
- Sponsor's protocol ID
- 2017YFC0111800
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He Q, Hou Y, Xu X, Li J, Zhao X, Xu Y, Zhang Y, Zhao Y. Establishment and validation of an artificial intelligence-based system for identifying the culprit vessel in patients with ST-segment elevated myocardial infarction: the ALERT study. BMJ Digit Health Ai. 2025 Jun 30;1(1):e000010. doi: 10.1136/bmjdhai-2025-000010. eCollection 2025.
PubMed 42712329
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Diagnosis of ST-segment Elevated Myocardial Infarction by Artificial Intelligence-based Electrocardiographic System:The ALERT-Pilot Study
- ClinicalTrials.gov ID
- NCT03317691
- Acronym / sponsor ID
- 2017YFC0111800
- Keywords
- myocardial infarction, artificial Intelligence, 12 lead electrocardiogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 15 Oct 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 23 Oct 2017 (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 algorithm of artificial intelligent to diagnose myocardial infarction through prior surgery Electrocardiogram was established. The accuracy of using artificial intelligent to diagnose acute ST-segment elevation myocardial infarction and judge criminal vascular was evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ST segment Elevation Myocardial Infarction | – | Diagnostic Test: electrocardiogram diagnosed by artificial intelligenceST segment Elevation Myocardial Infarction patients' diagnosis was confirmed by coronary artery angiography. The prior surgery electrocardiogram need to be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ST segment Elevation Myocardial Infarction patients' diagnosis was confired by coronary artery angiography. The prior surgery electrocardiogram need to be collected.
Key inclusion criteria (2 listed)
- age≥18 years old;
- the admitting doctor's diagnosis is ST-segment Elevation Myocardial Infarction.
Key exclusion criteria (4 listed)
- the admitting diagnosis is non-ST-segment Elevation Myocardial Infarction.
- default data;
- pregnancy, mental disorder, kidney failure;
- except for criteria mention above, including some improper condition considered by investigators.
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 |
|---|---|---|
| electrocardiogram diagnosed by artificial intelligenceAccording to coronary angiogram results, the accuracy of STEMI patients' electrocardiogram diagnosis by artificial intelligence was evaluated. | Diagnostic test | ST segment Elevation Myocardial Infarction |
Primary outcome
the algorithm of artificial intelligent to diagnose myocardial infarction through prior surgery Electrocardiogram
Time frame: 24 hours
All the electrocardiograms done before coronary arteriography were read by artificial intelligent. Then according to results of coronary angiogram, artificial intelligent can establish a algorithm of to diagnose myocardial infarction.
The accuracy of using artificial intelligent to diagnose acute ST-segment elevation myocardial infarction and judge criminal vascular
Time frame: 24 hours
The accuracy of using artificial intelligent to diagnose acute ST-segment elevation myocardial infarction and judge criminal vascular was evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Derived from this study: PubMed 42712329He Q, Hou Y, Xu X, Li J, Zhao X, Xu Y, Zhang Y, Zhao Y. Establishment and validation of an artificial intelligence-based system for identifying the culprit vessel in patients with ST-segment elevated myocardial infarction: the ALERT study. BMJ Digit Health Ai. 2025 Jun 30;1(1):e000010. doi: 10.1136/bmjdhai-2025-000010. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, Acute and Artificial Intelligence, run by Shanghai 10th People's 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yawei Xu, Professor (+86 02166306920, xuyaweicn@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the algorithm of artificial intelligent to diagnose myocardial infarction through prior surgery Electrocardiogram (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317691, which also lists 1 linked publication.
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 14 Nov 2017.