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

University Hospital Center (CHU) Dijon Bourgogne

Status: Enrolling

Conditions: Type A Aortic Dissection With Residual Type B Dissection; Chronic Type B Aortic Dissection

Treatments: Other: MRI with 4D flow imaging; Biological: blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT07315178

BOUCHOT FEDER 2024

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Type B aortic dissection

Experimental group

Treatment:

Biological: blood sampling

Other: MRI with 4D flow imaging

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

Experimental group

Treatment:

Biological: blood sampling

Other: MRI with 4D flow imaging