Recruiting

NCT Number: NCT07315178

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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Location status: Recruiting

Location contact

Alain Lalande

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI with 4D flow imaging

Other

At 3 months

Blood sampling

Biological

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

Primary outcomes

Relevance of combining biomarkers

Time frame: 3 months, 1 year, 2 years, 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Alain Lalande

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon