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临床试验/NCT02161471
NCT02161471已完成不适用

Haemodynamics and Function of the Atria in Patients with Congenital Heart Defects - Pilot Study by Cardiovascular Magnetic Resonance

University Children's Hospital, Zurich1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2009年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Right and left atrial volume

研究概览

简要总结

The purpose of this study is to determine whether patients with repaired congenital heart disease show differences in size or function of their heart atria compared to normal controls and depending on the nature of their heart disease.

详细描述

Atrial function is important for good ventricular filling and function. In patients with impaired cardiac function, atrial contraction is even more important. So far, the size and function of the atria have been assessed two-dimensionally by angiography and by echocardiography. However, these do not allow exact characterization of the volumetric changes of the atria during the cardiac cycle. Recently, cardiac magnetic resonance (CMR) has been used to assess size and function of the left atrium in adults. Little data are available about function and volume of the atria in children and the role of the atria in congenital heart disease (CHD).

The study will recruit patients with CHD (n=40) and normal controls (n=10). The patient group will be composed by patients suffering from the following conditions: coarctation of the aorta (n=10), tetralogy of Fallot (n=10), transposition of the great arteries after atrial switch (Senning procedure) (n=10), transposition of the great arteries after arterial switch operation (n=10).

The study consists of measurements of sizes and function of the right and the left atrium, respectively, by examining three-dimensional volume changes across the heart cycle, and of phase contrast measurements of blood flow across the valves of the heart.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Ability to perform repetitive breath holds of 10-15 seconds each
  • Written informed consent of the patients or their legal guardians

排除标准

  • Patients requiring general anaesthesia
  • Residual cardiac findings which might potentially influence the size and function of the atria

结局指标

主要结局

Right and left atrial volume

时间窗: Day of CMR (baseline only, no intervention)

Measurement of maximal volume (at end of systole), volume before atrial contraction (in late diastole), and minimal volume (at end of diastole) of both atria.

次要结局

  • Blood flow across the atrio-ventricular valves(Day of CMR (baseline only, no intervention))

研究者

发起方
University Children's Hospital, Zurich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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