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临床试验/NCT02980614
NCT02980614已完成不适用

Cardiac 4D MR Velocity Mapping in Repaired Tetralogy of Fallot Patients: Evaluation of Pulmonary Regurgitant Fraction and Ventricular Volume

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年3月27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
21
试验地点
2
主要终点
Regurgitant fraction comparison

研究概览

简要总结

MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence.

详细描述

MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence. The objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D MR-flow in repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery tree (PA flow =LeftPA flow +RightPA flow ? ).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Tetralogy of Fallot patients
  • referred for clinical MRI examination
  • ≥ 15 years

排除标准

  • Anyone with a classic contraindication to MRI
  • Severe obesity
  • Gadolinium chelate allergy
  • < 15 years
  • counter-indication to MRI examination
  • vulnerable person

研究组 & 干预措施

Participants to 4D flow imaging

Experimental

In addition to the standard clinical MR protocol, 2 added sequences:

4D MR sequence in cine mode 4D velocity mapping sequence

干预措施: 4D flow imaging (Device)

结局指标

主要结局

Regurgitant fraction comparison

时间窗: Day 0

The primary objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured with 4D MR-flow and standard 2D MR-flow.

次要结局

  • Pulmonary arteries flows(Day 0)
  • Right ventricular volume(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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