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临床试验/NCT02426203
NCT02426203Unknown不适用

Three-dimensional Echocardiographic Assessment of Right Ventricular Function in Patients Undergoing Pulmonary Endarterectomy

Papworth Hospital NHS Foundation Trust0 个研究点目标入组 51 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
51
主要终点
Right ventricular ejection fraction

研究概览

简要总结

Chronic thromboembolic pulmonary hypertension causes progressive right heart hypertrophy, dilatation and dysfunction. Surgical treatment is pulmonary endarterectomy, which although only carried out in a single UK centre, provides an excellent model for assessing right ventricular function. Right heart function is most commonly assessed using echocardiography, either transthoracic pre- and post-operatively, or transoesophageal intra-operatively. Measurement of tricuspid annular plane systolic excursion is the best validated and most commonly performed measurement for right heart function, however it may be inaccurate after sternotomy and pericardial opening, making accurate assessment difficult immediately after surgery. Therefore, we aim to compare established methods of assessing right heart function with 3-dimensional echocardiographic reconstruction of the ventricle, using a novel reconstruction mechanism. Right ventricular function will be assessed in 51 patients who undergo pulmonary endarterectomy surgery at baseline, after the pericardium has been opened, following the surgical procedure, using transoesophageal echocardiography, and at six-month outpatient followup using transthoracic echocardiography, as 3D-reconstruction is valid using both modalities. This comparison should allow the investigators to determine whether such a method could replace current measurement parameters for assessment of right ventricular function, which is important for clinical management of patients in a variety of settings.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Adult patients
  • undergoing pulmonary endarterectomy surgery at Papworth Hospital
  • Willing to provide informed consent

排除标准

  • Patient refusal
  • Contraindication to transoesophageal echocardiography
  • Technical difficulty preventing adequate echocardiographic assessment of right heart function

结局指标

主要结局

Right ventricular ejection fraction

时间窗: 6 months

3-dimensional acquisition of right ventricular ejection fraction using echocardiography

次要结局

  • Right ventricular fractional area change(6 months)
  • Tricuspid annular plane systolic excursion(6 months)
  • Right ventricular strain(6 months)
  • Left ventricular ejection fraction(6 months)
  • Pulmonary artery acceleration time(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

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