跳至主要内容
临床试验/NCT07315178
NCT07315178招募中不适用

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

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年11月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Relevance of combining biomarkers

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Type B aortic dissection

Experimental

干预措施: MRI with 4D flow imaging (Other)

Type B aortic dissection

Experimental

干预措施: blood sampling (Biological)

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

Experimental

干预措施: MRI with 4D flow imaging (Other)

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

Experimental

干预措施: blood sampling (Biological)

结局指标

主要结局

Relevance of combining biomarkers

时间窗: 3 months, 1 year, 2 years, 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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