Creation of a Digital Twin for Predicting the Progression of Patients With Chronic Thoracic Aortic Dissection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI with 4D flow imaging, blood sampling.
- Who it may be relevant to
- Registry conditions: Type A Aortic Dissection With Residual Type B Dissection, Chronic Type B Aortic Dissection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Relevance of combining biomarkers [Time frame: 3 months, 1 year, 2 years, 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Chu Dijon Bourgogne — Dijon
Identifiers
NCT: NCT07315178 · BOUCHOT FEDER 2024