跳至主要内容
临床试验/NCT04439942
NCT04439942已完成不适用

4D Flow Cardiac MRI Velocity Mapping in Patients With Hypertrophic Cardiomyopathy: Assessment of the Severity of the Left Ventricular Obstruction and Comparison With Echocardiography

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography.

研究概览

简要总结

Hypertrophic cardiomyopathy (HCM) is a frequent cardiac pathology with an estimated prevalence of 1/500 in France. The main risk factor for sudden death in this pathology is the presence and extent of left ventricular obstruction. To date, the only method allowing a reliable assessment of the extent of left ventricular obstruction is Doppler echocardiography. All patients with HCM should undergo cardiac magnetic resonance imaging (MRI) to confirm the diagnosis and for the detection of fibrosis, but conventional sequences cannot reliably assess the obstruction. 4D-flow MRI provides a complete coverage of an entire volume with the ability to simultaneously measure the outputs of all vessels within that volume in a single sequence and might be able to quantify left ventricular obstruction.

The main objective of this study is to compare the quantification of left ventricular obstruction in hypertrophic cardiomyopathy by Doppler echocardiography and 4D flow MRI.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Age ≥ 18 years old
  • Presence of a Hypertrophic cardiomyopathy (HCM)
  • Affiliation to a social security program
  • Ability of the subject to understand and express opposition

排除标准

  • Major obesity (> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70cm,
  • Age < 18,
  • Person under guardianship or curators,
  • Pregnant woman,
  • Allergy to gadolinium chelates,
  • Claustrophobia,
  • Any contraindications to MRI

结局指标

主要结局

Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography.

时间窗: day 1

Correlation coefficient assessment between the maximum gradient obtained by 4D flow

次要结局

  • Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast(day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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