跳至主要内容
临床试验/NCT07299227
NCT07299227招募中不适用

Impact of Balloon Pulmonary Angioplasty in CTEPH on Cardiac and Pulmonary Physiology as Assessed by State-of-the-art Cardiovascular Magnetic Resonance 4D Flow Haemodynamics

Kerckhoff Klinik1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Impact of BPA on cardio-pulmonary vascular physiology

研究概览

简要总结

Patients with CTEPH referred for evaluation and conduction of BPA undergo standard of care diagnostic tests and treatment. This includes conventional echocardiographic, RHC and non-invasive (CT/CMR) or invasive (coronary angiography) coronary artery disease work-up. BPA will be conducted in generally 5 to 6 consecutive sessions. CMR will be performed prior to first and following the last intervention. Patient recruitment will be performed within 3 years, that is the last BPA session of the last patient in will have been performed at 3 years time.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient referred to BPA
  • clinical indication for CMR
  • capability to give informed consent

排除标准

  • general: non-compliance, <18 years of age, pregnancy
  • contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR <30ml/min), allergies (medications)

结局指标

主要结局

Impact of BPA on cardio-pulmonary vascular physiology

时间窗: 1 year

2c) Changes in pulmonary artery flow (pulse wave velocity m/s)

次要结局

  • Impact of BPA on cardio-pulmonary vascular physiology(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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