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临床试验/NCT02467062
NCT02467062已完成不适用

Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
the bloodflow pattern

研究概览

简要总结

The aim of the investigator is to implement 4D FLOW MRI technique into a clinical setting and evaluate the blood flow pattern and wall sheer stress in patients with aortic and/or aortic valve diseases.

详细描述

Currently, the timing of the replacement of the ascending aorta is solely based on the aortic diameter and concomitant valvular dysfunction and the most recent ESC guideline proposes surgical intervention of ascending aortic aneurysm in patients who have a maximal aortic diameter ≥ 55mm, regardless of etiology. On the contrary, a recent publication by Rylski et al showed that most of the dissections occur at diameters smaller than 55 mm. Several publictions have shown that the flow profile and wall sheer stress derived from 4D flow MRI are significantly different between the valve morphology, the type of the aneurysm (tubular or diffuse enlargement) and pre and postoperative patients. Clinical implementation of 4D flow may enable us to stratify the patients with aortic and/or aortic valve diseases, especially in regard to the risk of ruptures. The patients with aortic/aortic valve disease will be referred to 4D flow MRI and contrast-enhanced angiografie from the aorta clinic. Phase 1: 6 healty adult volunteers will be scanned prior to the scan of the patients and settings would be optimised for 4D flow MRI and the contrast will not be given.

Phase 2: 30 patients either scheduled for surgical treatment of their aortic disease, post-operative patients and patients under surveillance for known aortic root and/or aortic valve disease will be imaged. Only patients having a clinical indication for an MRI of the aorta/aortic valve will be included.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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
是

入选标准

  • •Patients with aortic aneurysm and/or aortic valve disease older than 18 years.

排除标准

  • •Patients <18 years
  • •Pregnancy.
  • •Patients who have known contraindiction of MRI (ex claustrophobia, ICD, insulin pump etc)

研究组 & 干预措施

4Dflow MRI parallel imaging

Active Comparator

4D flow MRI with conventional parallel imaging

干预措施: MRI (Device)

4D flow ktARC parallel imaging

Other

4D flow MRI kt ARC spatiotemporal parallel imaging

干预措施: MRI (Device)

结局指标

主要结局

the bloodflow pattern

时间窗: 1 day

次要结局

  • wall sheer stress(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Veerle Van Mossevelde

Data Nurse

Universitair Ziekenhuis Brussel

研究点 (1)

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