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
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
- 否
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
研究点 (1)
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