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临床试验/NCT05103852
NCT05103852已完成不适用

Feasibility, Safety and Diagnostic Input of Interventional Cardiac MRI on a Series of 35 Patients With an Indication of Right Cardiac Catheterization.

GCS Ramsay Santé pour l'Enseignement et la Recherche2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年12月13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
35
试验地点
2
主要终点
Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation

研究概览

简要总结

The aim of this study is to evaluate the feasibility of collecting hemodynamic data from right catheterization, all anatomical, functional, flow and substrate determination data under MRI navigation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Patient over 18 years old
  • Having an indication for a diagnostic of right cardiac catheterization at the J Cartier Hospital for one of the following pathologies: dilated, restrictive cardiomyopathy, pulmonary arterial hypertension, chronic constrictive pericarditis, chronic post-embolic pulmonary heart.
  • Subject affiliated or beneficiary of a social security scheme
  • Patient having freely signed the informed consent.

排除标准

  • Pregnancy (declarative, known pregnancy, any unexplained period delay in a woman of childbearing age)
  • Presence of a contraindication to MRI: intraocular metallic splinter, surgical clip for cerebral aneurysm, claustrophobia, defibrillator, implanted electronic equipment) or to gadolinium chelates (anaphylactic reactions to gadolinium chelates, creatinine clearance <= 30 ml / min).
  • Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.
  • Patient participating in another clinical study

研究组 & 干预措施

Patients with right cardiac catheterization

Experimental

干预措施: Cardiac MRI (Procedure)

结局指标

主要结局

Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation

时间窗: 24 hours

Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation, as well as all the anatomical, functional, flow and substrate determination data by magnetic resonance (N / 35,%).

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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