NCT07117825

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Sep 2024Dec 2027

Study Start

First participant enrolled

September 30, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

August 5, 2025

Last Update Submit

August 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giovanni Tinelli

Roma, Italy

Location

MeSH Terms

Conditions

Aortic DiseasesAortic Dissection

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDissection, Blood VesselAneurysmAcute Aortic Syndrome

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

September 30, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations