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临床试验/NCT03667391
NCT03667391Unknown不适用

Taiwan Cohort - Chronic ThromboEmbolic Pulmonary Hypertension Registry

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年1月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
To investigate the geodemographics of CTEPH in Taiwan

研究概览

简要总结

The diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) is difficult for numerous reasons and is related with a poor prognosis. In Taiwan, the incidence of CTEPH and its clinical features are unknown. This study aims at evaluating the prevalence, clinical characteristics, and management of CTEPH in a Taiwanese cohort.

Primary objective:

  • To investigate the geodemographics of CTEPH in Taiwan

Secondary objectives:

  • To characterize the demographics and clinical presentation of patients with CTEPH
  • To describe the real-world management and treatment outcome of patients with CTEPH
  • To identify the risk factors of CTEPH
  • To assess the relationship between risk factors/patients' characteristics and clinical outcomes for CTEPH
  • To evaluate the prognosis of CTEPH in Taiwan using survival assessment

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Right heart catheterization (RHC) results that are in line with both of the following haemodynamic levels:
  • Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg at rest AND Pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg
  • Confirmation of CTEPH diagnosis by one of the following as recommended by standard guidelines:
  • At least 1 (segmental) perfusion defect(s) in ventilation-perfusion (V/Q) / perfusion scan OR Pulmonary artery obstruction seen by multidetector computed tomography (MDCT) angiography or conventional pulmonary cineangiography.
  • Presence of pulmonary hypertension or evidence of pulmonary thromboembolism after at least 3 months of anticoagulation treatment.

排除标准

  • not written informed consent
  • not meet inclusion criteria

结局指标

主要结局

To investigate the geodemographics of CTEPH in Taiwan

时间窗: recruiting period two years

variables of interest also include (1) patients characteristics, such as demographics and medical history; (2) clinical features and diagnosis records, such as risk factors, comorbidities, CTEPH diagnosis data, concomitant conditions; (3) management of CTEPH, including surgery and medication; and (4) clinical outcome including clinical assessment results, survival status, and clinical worsening related to CTEPH.

次要结局

  • To characterize the demographics and clinical presentation of patients with CTEPH - To describe the real-world management and treatment outcome of patients with CTEPH - To identify the risk factors of CTEPH - To assess the relationship between risk f(recruiting period two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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