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

NCT ID: NCT07315178

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-25

Study Completion Date

2031-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type A Aortic Dissection With Residual Type B Dissection Chronic Type B Aortic Dissection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Type B aortic dissection

Group Type EXPERIMENTAL

MRI with 4D flow imaging

Intervention Type OTHER

At 3 months

blood sampling

Intervention Type BIOLOGICAL

2 tubes of 10 ml blood at inclusion, at 3 months, at 12 months, at 24 months and at 36 months

Residual type B aortic dissection following surgery for type A aortic dissection

Group Type EXPERIMENTAL

MRI with 4D flow imaging

Intervention Type OTHER

At 3 months

blood sampling

Intervention Type BIOLOGICAL

2 tubes of 10 ml blood at inclusion, at 3 months, at 12 months, at 24 months and at 36 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI with 4D flow imaging

At 3 months

Intervention Type OTHER

blood sampling

2 tubes of 10 ml blood at inclusion, at 3 months, at 12 months, at 24 months and at 36 months

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alain Lalande

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alain Lalande

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BOUCHOT FEDER 2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.