STEMIPredict AINCT07866144
Prediction of Adverse Events From Non-PCI Coronary Plaques Using Machine Learning
An observational study of STEMI and NSTEMI, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
The aim of our project is to predict, with the help of artificial intelligence (AI) and machine learning techniques, the natural history of non-flow-limiting coronary stenoses and to develop and validate a machine learning risk score able to estimate the risk of MACE during follow-up based on OCT findings observed on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI, NSTEMI, Chronic Coranary Sindrome
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 1 Jul 2026
- 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: Men and women over 18 years of age, presenting with STEMI - NSTEMI - CCS - UA.
Who may be able to join
- Age >18 Years
- STEMI - NSTEMI - CCS - UA
Who cannot join
- Age < 18 Years
- NO STEMI - NSTEMI - CCS - UA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Adverse Events From Non-PCI Coronary Plaques Using Machine Learning: the Predict-AI Study
The aim of our project is to predict, with the help of artificial intelligence (AI) and machine learning techniques, the natural history of non-flow-limiting coronary stenoses and to develop and validate a machine learning risk score able to estimate the risk of MACE during follow-up based on OCT findings observed on coronary plaques not subjected to percutaneous coronary intervention (PCI) and on the clinical characteristics of the patients.
We will collect information on all non-PCI coronary lesions assessed by performing OCT in non-culprit vessels of patients presenting with ACS or Chronic Coronary Syndrome (CCS) at the index procedure. All OCT runs will be digitized and analyzed with the help of AI. The OCT appearance of coronary plaques will be analyzed with AI and correlated with the risk of MACE during follow-up (a composite of cardiac death, myocardial infarction, or target lesion revascularization). An AI predictive risk model based on coronary plaque OCT images and patient clinical characteristics will be developed to estimate the risk of MACE incidence at follow-up. Cutting-edge machine learning algorithms, including convolutional neural networks, random forests, and support vector machines, will be used.
- Conditions
- STEMI, NSTEMI, Chronic Coranary Sindrome, Unstable Angina (UA)
- Keywords
- Acute coronary syndrome, OCT, AI, Unstable Angina, Chronic Coronary Syndrome, IVUS
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Angina, Unstable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with OCT performed on non stented vessel: training and test cohoort | Not described | |
| Patients with OCT performed on non stented vessel: external validation cohoort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Composite end point of all cause death, MI, urgent revascularization and TVR
Measured: 12 months
MACCE
composite end point of CV death, MI, urgent revascularization and TVR
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jan 2023
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Collaborators
- Ministero dell'Istruzione, dell'Università e della Ricerca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866144
- Sponsor's protocol ID
- PREDICT AI
- Acronym
- Predict AI
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2026
- Last updated
- 8 Oct 2026
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Adverse Events From Non-PCI Coronary Plaques Using Machine Learning: the Predict-AI Study
- ClinicalTrials.gov ID
- NCT07866144
- Acronym / sponsor ID
- Predict AI / PREDICT AI
- Conditions
- STEMI, NSTEMI, Chronic Coranary Sindrome, Unstable Angina (UA)
- Keywords
- Acute coronary syndrome, OCT, AI, Unstable Angina, Chronic Coronary Syndrome, IVUS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Collaborators
- Ministero dell'Istruzione, dell'Università e della Ricerca
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 8 Oct 2026 (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 our project is to predict, with the help of artificial intelligence (AI) and machine learning techniques, the natural history of non-flow-limiting coronary stenoses and to develop and validate a machine learning risk score able to estimate the risk of MACE during follow-up based on OCT findings observed on coronary plaques not subjected to percutaneous coronary intervention (PCI) and on the clinical characteristics of the patients.
We will collect information on all non-PCI coronary lesions assessed by performing OCT in non-culprit vessels of patients presenting with ACS or Chronic Coronary Syndrome (CCS) at the index procedure. All OCT runs will be digitized and analyzed with the help of AI. The OCT appearance of coronary plaques will be analyzed with AI and correlated with the risk of MACE during follow-up (a composite of cardiac death, myocardial infarction, or target lesion revascularization). An AI predictive risk model based on coronary plaque OCT images and patient clinical characteristics will be developed to estimate the risk of MACE incidence at follow-up. Cutting-edge machine learning algorithms, including convolutional neural networks, random forests, and support vector machines, will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with OCT performed on non stented vessel: training and test cohoort | – | – |
| Patients with OCT performed on non stented vessel: external validation cohoort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women over 18 years of age, presenting with STEMI - NSTEMI - CCS - UA.
Key inclusion criteria (2 listed)
- Age >18 Years
- STEMI - NSTEMI - CCS - UA
Key exclusion criteria (2 listed)
- Age < 18 Years
- NO STEMI - NSTEMI - CCS - UA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE
Time frame: 12 months
Composite end point of all cause death, MI, urgent revascularization and TVR
MACCE
Time frame: 12 months
composite end point of CV death, MI, urgent revascularization and TVR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 STEMI and NSTEMI, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 8 Oct 2026. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 12 months). 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?
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 8 Oct 2026.