跳至主要内容
临床试验/NCT04257747
NCT04257747招募中不适用

Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
46
试验地点
2
主要终点
Variation of ulnar artery vascular flows between healthy volunteers and patients with forearm flap reconstruction

研究概览

简要总结

Allotransplants of vascularized composite tissues are subject to chronic vascular rejection, which can lead to graft loss. Currently, no imaging technique allows a reproducible quantitative exploration of the arterial trees of the hand, and therefore a satisfactory monitoring of transplants. Since 2014, flow MRI has been applied to the analysis of small-calibre arteries by the Image Processing Team at the Amiens-Picardie University Hospital. Between 2015 and 2017, several acquisitions were made in 3 patients who received facial allotransplantation, and the team recently developed a flow MRI protocol dedicated to the study of arterial trees in the hand.

The main objective is to measure vascular flows of radial, ulnar and interdigital arterial trees in normal (healthy volunteers) and pathological situations (patients with radial forearm flap reconstruction and patients with hand allotransplantation) using the specifically developed flow MRI protocol.

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
Single (Participant)

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

  • Adult (≥ 18 years old)
  • patients who has received appropriate information and provided informed consent
  • patients benefiting from social security insurance
  • patients with no contraindications to magnetic resonance imaging
  • healthy volunteer or patient requiring radial forearm flap reconstruction or having received hand allotransplantation.

排除标准

  • Person with a contraindication to MRI
  • pregnant or breastfeeding woman
  • minors (< 18 years)
  • person under guardianship or deprived of liberty by a judicial or administrative decision
  • person with upper limb arteriopathy with the exception of the hand transplant patients group.

结局指标

主要结局

Variation of ulnar artery vascular flows between healthy volunteers and patients with forearm flap reconstruction

时间窗: day 0

Ulnar artery vascular flows between healthy volunteers and patients with forearm flap reconstruction will be determined by using the specifically developed flow MRI protocol

Variation of radial vascular flows between healthy volunteers and patients with forearm flap reconstruction

时间窗: day 0

Radial vascular flows between healthy volunteers and patients with forearm flap reconstruction will be determined by using the specifically developed flow MRI protocol

Variation of radial vascular flows between healthy volunteers and patients with hand allotransplantation

时间窗: day 0

Radial vascular flows between healthy volunteers and patients with hand allotransplantation will be determined by using the specifically developed flow MRI protocol

Variation of ulnar artery vascular flows between healthy volunteers and patients with hand allotransplantation

时间窗: day 0

Ulnar artery vascular flows between healthy volunteers and patients with hand allotransplantation will be determined by using the specifically developed flow MRI protocol

Variation of interdigital arterial tree vascular flows between healthy volunteers and patients with forearm flap reconstruction

时间窗: day 0

Interdigital arterial tree vascular flows between healthy volunteers and patients with forearm flap reconstruction will be determined by using the specifically developed flow MRI protocol

Variation of interdigital arterial tree vascular flows between healthy volunteers and patients with hand allotransplantation

时间窗: day 0

Interdigital arterial tree vascular flows between healthy volunteers and patients with hand allotransplantation will be determined by using the specifically developed flow MRI protocol

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 (2)

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