Active, not recruitingNCT07117825ADAGIOUpdated Aug 12, 2025

Aortic Dissection fAlse enlarGement radIomics predictiOn

An observational study in Dissection, Aortic Diseases and Aortic Dissection, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-12.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 500
Ages: 18 Years and older
Sex: All

Study summary

The objective of this study is to find, in acute phase of aortic dissection, CT scans characteristics through radiomics features, that can help us to predict a significant growth of dissected descending aorta or a false lumen enlargement in order to treat the patient promptly.

Conditions studied

Dissection
Aortic Diseases
Aortic Dissection

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Sampling method: Non-probability sample

Study population

Patients with type A or type B acute aortic dissection, treated either with medical therapy or with endovascular/open surgery in the study period and who underwent subsequent radiological follow-up.

Inclusion criteria

Patients with previous acute aortic (type A or B) dissection, undergoing medical or surgical therapy and in clinical-radiological follow-up.

Exclusion criteria

Exclusion Criteria:

Patients with no appropriate radiological follow up;
Patients who died in the acute phase of aortic type A or B dissection.

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 500 participants (estimated)
Patient registry: No

Interventions

OtherAORTIC DISSECTION CT SCAN ANALYSIS
Patients with type A or type B acute aortic dissection, treated either with medical therapy or with endovascular/open surgery in the study period and who underwent subsequent radiological follow-up.

What researchers measure

Primary outcomes

Predict the false lumen enlargement (>5.5 mm aortic diameter growth at CT follow-up control) through radiomics analysis applied on CT scans.
Time frame: 24 MONTHS

Study locations

1 site

Giovanni Tinelli
Roma, Italy

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07117825
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party: TINELLI GIOVANNI (Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted: Aug 12, 2025
Start date: Sep 30, 2024
Primary completion: Jan 1, 2026 (estimated)
Completion: Dec 31, 2027 (estimated)
Last update: Aug 12, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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