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临床试验/NCT04091919
NCT04091919已完成不适用

Assessment of Left and Right Ventricular Strain and Strain Rate Before and After Percutaneous Closure of Atrial Septal Defects in Adults and Adolescents

Ayman khairy Mohamed2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月1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
50
试验地点
2
主要终点
Measure change from baseline in the biventricular function of the ASD group

研究概览

简要总结

The effect of Atrial Septal Defect (ASD) closure by using larger devices on the improvement in biventricular function remains an area of active research. Therefore, the aim of the current study is to assess the degree of improvement in biventricular dimensions and function by using 2-Dimensional echocardiography derived Strain and Strain Rate and Tissue Doppler. Moreover, to identify the relationship between the left and right ventricular systolic and diastolic function and device size.

详细描述

In most echocardiographic studies, left ventricle (LV) systolic function was normal in the patients with ASD and only a few cases had a reduced LV ejection fraction with severe right ventricle (RV) volume overload. The device closure of ASD increases immediately the blood flow to the left ventricle and may unmask subtle abnormalities in systolic and diastolic function. Currently, clinical research in cardiac mechanics is moving from short- and long-axis LV and RV function and ejection fraction to two and three- dimensional (2D, 3D) ventricular deformation studies (Strain and Strain Rate quantification). These methods are independent of ventricular geometry and allow quantification of myocardial motion and deformation in different directions (longitudinal, radial, and circumferential), while conventional methods mainly rely on the assessment of radial function. Strain imaging has also been used to demonstrate that patients who underwent device closure of an ASD had better LV and RV longitudinal deformation than patients who underwent surgical closure of an ASD. However, the effect of device size on the LV systolic and diastolic function is still under investigations. For all these reasons the researchers intend to measure RV and LV haemodynamic changes by 2-D Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain quantification in ASD before and after transcatheter closure with special emphasis on the assessment of the relationship between device size and biventricular systolic and LV diastolic function.

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
11 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All ASD patients who have been already selected and suitable for intervention before the starting time of the study. The criteria for ASD intervention are either haemodynamically significant shunt fraction (Qp/Qs > 1.5) or echocardiographic signs of right heart dilation or RV volume overload and pulmonary hypertension related symptoms.

排除标准

  • Patients with a large stretched Secundum ASD ≥ 36 mm, those with insufficient ASD rims (except the aortic rim), sinus venosus or primum type ASD, irreversible pulmonary hypertension, other associated structural heart diseases, coronary artery disease, LV systolic dysfunction, atrial fibrillation, or hypertension.

结局指标

主要结局

Measure change from baseline in the biventricular function of the ASD group

时间窗: 1-3 month

Change from baseline in Biventricular systolic function and LV diastolic function of the ASD group will be measured by using 2D Echocardiography (derived Strain, Strain Rate and Tissue Doppler Imaging) at 24 hours and one month after transcatheter ASD device closure procedure.

Measure the biventricular geometry and function of the control group

时间窗: Baseline

The control group LV/RV geometry and function values will be evaluated by using 2D Transthoracic Echocardiography.

Measuring of the biventricular geometrical changes before and after ASD device closure

时间窗: 1-3 month

The LV and RV geometrical changes of the ASD group will be evaluated by using standard 2D Transthoracic Echocardiography before, 24 hours and one month after transcatheter ASD device closure procedure. The geometrical changes include LV and RV dimensions, pressure and wall masses.

Measure the relationship between the geometrical and function changes and device size of the ASD group

时间窗: 1-3 month

The waist size of the selected device that will be used in transcatheter closure of the ASD will be documented according to the diameter of defect by using Transoesophageal Echocardiography before and during the closure procedure. Then, the relationship between the LV/RV geometrical and function changes after transcatheter closure and the used device size will be measured.

次要结局

未报告次要终点

研究者

发起方
Ayman khairy Mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ayman khairy Mohamed

Clinical Professor

Assiut University

研究点 (2)

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