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临床试验/NCT02952287
NCT02952287终止不适用

Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique

The Hospital for Sick Children0 个研究点目标入组 100 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
100
主要终点
Pearson´s correlation coefficient (r)

研究概览

简要总结

The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR with 2D PC flow measurement.

详细描述

Measurement of blood flow in vessels leading to or arising from the heart is one of the key features of Cardiac Magnetic Resonance (CMR). With standard 2D phase contrast (PC) flow measurements, each vessel is measured separately at a predefined location. Planning and scanning can be time consuming while the patient is inside the scanner. In addition, when the scan time is long, the hemodynamics may be assessed at different physiological states. In contrast to a 2D PC acquisition 4D PC captures all the information about blood flow velocities within a 3D anatomical volume. Once this predefined volume has been acquired, the flow within the heart and vessels of interest can be measured at any desired location offline, i.e. after the patient has left the scanner. This is especially advantageous in cases where multiple 2D PC MRI scans are needed such as in congenital heart disease (CHD). In addition to standard measurements, 4D PC provides flow patterns, which might change our current understanding of pathologic flow conditions. Although there has been increasing interest in this new technique, only a few papers have proved its accuracy in adult population. The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR with 2D PC flow measurement.

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
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All pediatric patients under 18 years of age undergoing CMR with 2D PC flow measurements as a clinically indicated component of the examination at The Hospital for Sick Children, Toronto, ON.
  • Ability to undergo an MRI examination without anesthesia or sedation.
  • Ability to undergo an MRI examination using 'Feed-and-Sleep' technique39

排除标准

  • Refusal of consent / assent by parent / legal guardian / patient
  • General contraindications for an MRI examination such as non-MRI compatible metallic implants, claustrophobia.
  • Patients who require anaesthesia or sedation for MRI

结局指标

主要结局

Pearson´s correlation coefficient (r)

时间窗: Six months

The association of variables (stroke volumes as measured with 2D and 4D flow, regurgitation fractions) will be investigated with Pearson´s correlation coefficient (r). P values of \<0.05 will be considered significant.

次要结局

未报告次要终点

研究者

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

Shi-Joon Yoo

Cardiac Radiologist

The Hospital for Sick Children

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