Aortic Dissection fAlse enlarGement radIomics predictiOn | NCT07117825

Studies
Aortic Dissection fAlse enlarGement radIomics predictiOn

NCT07117825

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Active, not recruiting

Last Update Posted

Aug 12, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Dissection
Aortic Diseases
Aortic Dissection

Interventions

AORTIC DISSECTION CT SCAN ANALYSIS

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2024Actual

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Aug 5, 2025

First Submission Date that Met QC Criteria

Aug 5, 2025

First Posted Date

Aug 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2025

Last Update Posted Date

Aug 12, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

TINELLI GIOVANNI, Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AORTIC DISSECTION CT SCAN ANALYSIS	Other	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001018	Aortic Diseases
D000784	Aortic Dissection

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D000094665	Dissection, Blood Vessel
D000783	Aneurysm

Browse Leaves

Not provided

Browse Branches

Not provided