Creation of a Digital Twin for Predicting the Progression of Patients With Chronic Thoracic Aortic Dissection (ADEPT)

December 18, 2025 updated by: Centre Hospitalier Universitaire Dijon

Aortic dissection causes a tear in the inner layers of the aorta, leading to the formation of a true and false lumen.

There are two types of dissection: type A, which affects the ascending aorta, and type B, which affects the descending aorta. Type A aortic dissection is almost always a surgical emergency and involves replacing the ascending aorta with a prosthesis. After this type of dissection, a residual dissection remains in the descending aorta, known as residual type B dissection, which becomes chronic. This requires increased monitoring by MRI or CT scan, which are currently not effective enough to predict the development of an aneurysm that could lead to aortic rupture requiring surgical intervention. Other factors such as blood flow, the forces and mechanisms regulating blood circulation, the mechanics and histology of the aorta, and blood markers could provide a more reliable prediction of the development of an aneurysm. The creation of a digital twin model incorporating all these factors should enable better patient management.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Person who has given written consent
  • Age > 18 years
  • Patient with type A aortic dissection with surgical indication for replacement
  • Patient with chronic type B aortic dissection, monitored and managed medically, not operated on

Exclusion Criteria:

  • Persons not affiliated with or not covered by a social security scheme
  • Persons subject to legal protection measures (guardianship)
  • Persons subject to judicial protection measures
  • Pregnant women, women in labour or breastfeeding
  • Adults who are incapacitated or unable to give their consent
  • Contraindications to MRI: claustrophobia, non-MRI-compatible metal implants, suspected metal foreign body
  • Severe renal failure (clearance <30ml/min according to Cockroft due to gadolinium injection)
  • Uncontrolled asthma
  • Patients with acute type A aortic dissection who died during or in the post-operative period following surgery to repair the dissection
  • Patients with a known allergy to gadolinium-based contrast agents
  • Patients treated for type B aortic dissection who underwent surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Type B aortic dissection
Other: MRI with 4D flow imaging
At 3 months
Biological: blood sampling
2 tubes of 10 ml blood at inclusion, at 3 months, at 12 months, at 24 months and at 36 months
Experimental: Residual type B aortic dissection following surgery for type A aortic dissection
Other: MRI with 4D flow imaging
At 3 months
Biological: blood sampling
2 tubes of 10 ml blood at inclusion, at 3 months, at 12 months, at 24 months and at 36 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relevance of combining biomarkers
Time Frame: 3 months, 1 year, 2 years, 3 years
3 months, 1 year, 2 years, 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2025

Primary Completion (Estimated)

November 1, 2031

Study Completion (Estimated)

November 1, 2031

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOUCHOT FEDER 2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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