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临床试验/NCT02936349
NCT02936349已完成不适用

Correlation of Graded Transthoracic Contrast Echocardiography With Chest CT Findings After Pulmonary Arteriovenous Malformation Embolization in Patients With Hereditary Hemorrhagic Telangiectasia, 2016

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Differences between TTCE shunt grade and the number of PAVMs present on most recent chest CT scan.

研究概览

简要总结

Current HHT guidelines recommend CT scan to detect new or recurrent PAVMs after embolotherapy. Recent studies using transthoracic contrast echocardiography (TTCE) shunt grade for PAVM screening suggest that graded TTCE can accurately predict the size of PAVMs on chest CT and their amenability to embolization. This study's purpose is to evaluate whether TTCE shunt grade can also accurately predict PAVM size and amenability to treatment in patients who are post-embolization.

详细描述

Embolization is the standard of care for pulmonary arteriovenous malformations (PAVMs) in the Hereditary Hemorrhagic Telangiectasia (HHT) population. PAVMs are abnormal connections between the veins and arteries and result in right-to-left shunting of blood within the lungs. Successful embolization results in PAVM resolution and decreases the complications associated with right-to-left shunting. Current guidelines recommend follow-up with interval chest CT scan to determine treatment success and detect new or recurrent PAVMs after embolization. This results in significant radiation exposure to the relatively young HHT population. An alternative to chest CT is graded transthoracic contrast echocardiography (TTCE), which measures the amount of right-to-left shunting within the lung and assigns a grade based on this amount. TTCE has the advantage of being radiation free compared to chest CT. To date, graded TTCE has only been studied as a screening tool for PAVMs. These studies have shown that graded TTCE is highly sensitive in detecting PAVMs and is comparable to chest CT when screening for PAVMs. Results indicate that TTCE grade can accurately predict PAVM size on chest CT and predict whether PAVMs are amenable to embolization. However, no studies have compared graded TTCE and chest CT in patients who are post-embolization and it is therefore unknown whether graded TTCE can be used in patients who have undergone PAVM embolization. The current study seeks to correlate post-embolization TTCE grade with chest CT findings to determine whether TTCE can accurately predict PAVM size and amenability to treatment in the post-embolization population.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age range 18-89 years old
  • Diagnosis of Hereditary Hemorrhagic Telangiectasia by the Curacao criteria
  • Prior diagnosis of one or more PAVMs treated by embolotherapy
  • Chest CT performed within the Penn system for surveillance of PAVMs after \ embolotherapy

排除标准

  • Known PAVM recurrence on most recent chest CT with feeding artery size amenable to repeat embolotherapy
  • Known history of intracardiac shunt
  • Discovery of intracardiac shunt during transthoracic contrast echocardiography

结局指标

主要结局

Differences between TTCE shunt grade and the number of PAVMs present on most recent chest CT scan.

时间窗: At the time of the echocardiogram (TTCE)

Differences between TTCE shunt grade and the size of PAVMs present on most recent

时间窗: At the time of the echocardiogram (TTCE)

次要结局

  • Correlation between TTCE shunt grade to presence of PAVMs amenable to embolotherapy (feeding artery >2 mm) on most recent chest CT(48 hours after echocardiogram (TTCE))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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