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CompletedNCT07866144Predict AIUpdated Oct 8, 2026

Prediction of Adverse Events From Non-PCI Coronary Plaques Using Machine Learning

An observational study in STEMI, NSTEMI and Chronic Coranary Sindrome, sponsored by A.O.U. Città della Salute e della Scienza. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by A.O.U. Città della Salute e della Scienza · Observational

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • STEMI
  • NSTEMI
  • Chronic Coranary Sindrome
  • Unstable Angina (UA)

Keywords

  • Acute coronary syndrome
  • OCT
  • AI
  • Unstable Angina
  • Chronic Coronary Syndrome
  • IVUS
03

In context

ST Elevation Myocardial Infarction

688 studies on the registry are indexed under ST Elevation Myocardial Infarction; 184 are open to participants now.

This study's enrollment of 600 is above the median of 335 across 229 observational studies indexed under ST Elevation Myocardial Infarction.

Browse ST Elevation Myocardial Infarction studies →

Lead sponsor

A.O.U. Città della Salute e della Scienza is the lead sponsor of 65 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Men and women over 18 years of age, presenting with STEMI - NSTEMI - CCS - UA.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age >18 Years
  • STEMI - NSTEMI - CCS - UA

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 Years
  • NO STEMI - NSTEMI - CCS - UA
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
600 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with OCT performed on non stented vessel: training and test cohoort
  • Patients with OCT performed on non stented vessel: external validation cohoort
06

What researchers measure

Primary outcomes

  1. MACE

    Composite end point of all cause death, MI, urgent revascularization and TVR

    Time frame: 12 months

  2. MACCE

    composite end point of CV death, MI, urgent revascularization and TVR

    Time frame: 12 months

07

Study locations

1 site
  • AOU Città della Salute e della Scienza
    Turin, Italy 10126, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Jul 2026, 42 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2026
First posted
Oct 8, 2026
StartActual
Jan 1, 2023
Primary completionActual
Jul 1, 2026
CompletionActual
Jul 1, 2026
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07866144
Lead sponsor
A.O.U. Città della Salute e della Scienza
Collaborators
Ministero dell'Istruzione, dell'Università e della Ricerca
Responsible party
Sponsor
First posted
Oct 8, 2026
Start date
Jan 1, 2023
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026
Last update
Oct 8, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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