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临床试验/NCT04968431
NCT04968431Unknown不适用

Three Dimensional Versus Two Dimensional Echocardiography in Assessment of Severity and Scoring of Rheumatic Mitral Stenosis.

Assiut University0 个研究点目标入组 60 人开始时间: 2021年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
benefit of 3D echocardiography in mitral stenosis severity

研究概览

简要总结

Although the prevalence of rheumatic fever is decreasing in developed countries, it still affects numerous areas in the non- industrialized world. Untreated mitral stenosis (MS) contributes significantly to global morbidity and mortality. Echocardiography is the main diagnostic imaging modality for evaluation of mitral valve (MV) obstruction and assessment of severity and hemodynamic consequences of MS as well as valve morphology. According to current guidelines and recommendations for clinical practice, the severity of MS should not be defined by a single value but assessed by valve areas, mean Doppler gradients, and pulmonary pressures. Transthoracic echocardiography is usually sufficient to grade MS severity and to define the morphology of the valve. Transesophageal echocardiography is used when the valve cannot be adequately assessed with transthoracic echocardiography and to exclude intracardiac thrombi before a percutaneous or surgical intervention. Three-dimensional transthoracic and transesophageal echocardiographic assessment provide more detailed physiological and morphological information. Current definitive treatment for severe MS involves percutaneous balloon mitral valvuloplasty (PMBV) or surgery. The effectiveness of PMBV is related to the etiology of MS, and certain anatomic characteristics tend to predict a more successful outcome for PMBV, whereas other MV structural findings might suggest balloon valvuloplasty to be less likely successful or even contraindicated. Does 3D echo can add more useful information over 2 D echo that could change treatment decision?

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age range from 18 years to 60 years.
  • Patient with isolated mitral stenosis (except those with mild mitral regurgitation and are candidate for PTMC by 2D Echo evaluation).
  • Patient with normal left ventricular EF
  • patient both in sinus rhythm or atrial fibrillation

排除标准

  • Age below 18 years or above 60 years.
  • Patient with another valve lesion or more than mild mitral regurgitation.
  • Patient with impaired cardiac function.
  • Mitral stenosis of other etiology than rheumatic origin

结局指标

主要结局

benefit of 3D echocardiography in mitral stenosis severity

时间窗: 1 year

The added benefit of 3D echocardiography over 2D echo in evaluation of rheumatic mitral stenosis severity with pressure gradient

benefit of 3D echocardiography in mitral stenosis scoring

时间窗: 1 year

The added benefit of 3D echocardiography over 2D echo in evaluation of rheumatic mitral stenosis score

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

Ibrahim Sayed

resident doctor

Assiut University

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