DissectionADAGIONCT07117825
Aortic Dissection fAlse enlarGement radIomics predictiOn
An observational study of Dissection and Aortic Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dissection, Aortic Diseases, Aortic Dissection
- What is being tested?
- AORTIC DISSECTION CT SCAN ANALYSIS
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older 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.
Who may be able to join
- Patients with previous acute aortic (type A or B) dissection, undergoing medical or surgical therapy and in clinical-radiological follow-up.
Who cannot join
- Patients with no appropriate radiological follow up;
- Patients who died in the acute phase of aortic type A or B dissection.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Dissection, Aortic Diseases, Aortic Dissection
- Being tested
- AORTIC DISSECTION CT SCAN ANALYSIS
- Medical subject headings
- Aortic Diseases, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AORTIC DISSECTION CT SCAN ANALYSISOther
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 is being measured
The primary outcome is the main question the study is designed to answer.
Predict the false lumen enlargement (>5.5 mm aortic diameter growth at CT follow-up control) through radiomics analysis applied on CT scans.
Measured: 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start30 Sep 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DissectionStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117825
- Sponsor's protocol ID
- 6518
- Acronym
- ADAGIO
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Dissection fAlse enlarGement radIomics predictiOn
- ClinicalTrials.gov ID
- NCT07117825
- Acronym / sponsor ID
- ADAGIO / 6518
- Conditions
- Dissection, Aortic Diseases, Aortic Dissection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Aug 2025 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- Patients with previous acute aortic (type A or B) dissection, undergoing medical or surgical therapy and in clinical-radiological follow-up.
Key exclusion criteria (2 listed)
- Patients with no appropriate radiological follow up;
- Patients who died in the acute phase of aortic type A or B dissection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AORTIC DISSECTION CT SCAN ANALYSISPatients 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. | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- 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 Dissection and Aortic Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 1 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
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). 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 12 Aug 2025.