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临床试验/NCT05103189
NCT05103189已完成不适用

4D Flow Cardiac MRI Velocity Mapping in Patients With Pulmonary Hypertension: Estimation of Pulmonary Arterial Pressure and Comparison With Right Heart Catheterization and Doppler Echocardiography

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年10月21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
28
试验地点
2
主要终点
Correlation coefficient between the values of mPAP (mmHg) and right heart catheterization rate.

研究概览

简要总结

Due to radiation exposure and low but real risk of morbidity and mortality associated with right heart catheterization, non-invasive procedures to estimate mPAP are desired for the diagnosis of PH or to monitor treatment effectiveness. Echocardiography is used as a screening tool to estimate systolic pulmonary arterial pressure (sPAP), but due various limitations, this technique is not considered to be sufficiently accurate for the diagnosis of PH. The aim of 4D flow MRI is to evaluate the complete time-varying tridirectional velocity field in a volume of interest. It enables flow and velocity measurements in a vascular region of interest and visualization of vector plots of blood flow velocity fields. Previous studies have shown on the one hand, correlations between mPAP and hemodynamic parameters obtained by phase contrast MRI and, on the other hand, appearance of a vortical blood flow in the pulmonary artery in PH. More studies are required to confirm 4D MRI as a valuable tool for mPAP estimation in PH.

Following screening echocardiography, all patients will undergo right heart catheterization for PH assessment. Then, all patients will be referred for a complete cardiac MRI exam with the addition of a 4D Flow sequence (does not require supplementary injection of a contrast agent and does not extend the duration of the examination) followed promptly (within the same hour) by a Doppler-echocardiography. The data from each examination will be blindly interpreted from the results of the other one. No follow-up will be required for the study.

研究设计

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

入选标准

  • Age ≥ 18 years old,
  • Patient referred for cardiac MRI who previously underwent right heart catheterization for pulmonary hypertension assessment,
  • Affiliation to a social security program,
  • Ability of the subject to understand and express opposition

排除标准

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

结局指标

主要结局

Correlation coefficient between the values of mPAP (mmHg) and right heart catheterization rate.

时间窗: 30 minutes

mPAP is obtained by 4D flow MRI

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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