Chronic Thromboembolic Disease: A Prospective Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients undergoing lung transplantation
研究概览
简要总结
The goal of this patient registry is to learn about the natural history in patients with chronic thromboembolic disease (CTD) and/or chronic thromboembolic pulmonary hypertension (CTEPH). The main question[s] it aims to answer are:
- Long-term outcome after various types of treatment, including medication, balloon pulmonary angioplasty, and pulmonary endarterectomy
- Effect of treatment on patient's quality of life and exercise tolerance Participants will be followed longitudinally to assess their health outcomes and quality of life via chart review and health quality surveys.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred with CTED and/or CTEPH defined as:
- •Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest with pulmonary vascular resistance (PVR) > 2 Wood units (WU); or if mPAP ≤ 20 mmHg or PVR ≤ 2 WU at rest, have exercise limitations from chronic thromboembolic pulmonary disease (CTEPD) without pulmonary hypertension (PH)
- •Radiologic finding of chronic thromboembolic disease, including abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram
- •Post-embolic exercise intolerance and evidence of chronic thromboembolic disease in the absence of resting pulmonary hypertension
- •Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
- •Age ≥ 18 years
排除标准
- •Main cause of PH other than World Health Organization (WHO) group 4 (CTEPH)
- •Patient's refusal to participate in clinical research and/or receive intervention
研究组 & 干预措施
Chronic thromboembolic disease
Patients with chronic thromboembolic disease/pulmonary hypertension
干预措施: Survey (Other)
结局指标
主要结局
Number of patients undergoing lung transplantation
时间窗: Baseline to end of the study, an average of 5 years
Number of patients undergoing lung transplantation
Total number of patients who survive
时间窗: Through study completion, an average of 5 years
The total number of patients who are alive
Changes in exercise tolerance
时间窗: Baseline to end of the study, an average of 5 years
Measured by 6-min walk test, which will be done approximately every 3 months at follow up per standard of care
Changes in New York Heart Association (NYHA) functional class
时间窗: Baseline to end of the study, an average of 5 years
Grading of patients by NYHA functional class, which include functional capacity and objective assessment. This will be compiled at the end of the study to provide overall change in measurement.
Changes in supplemental oxygen use severity
时间窗: Baseline to end of the study, an average of 5 years
Number of patients on supplemental oxygen, which will be recorded approximately every 3 months at follow up per standard of care. This will be compiled at the end of the study to provide overall change in measurement.
European Quality of Life Five Dimension (EQ-5D) - Scale Score
时间窗: Baseline to end of the study, an average of 5 years
Assessment of quality of life will be measured using EQ-5D-5L. This instrument is a self-assessed, health-related, quality of life questionnaire that measures quality of life on a 5-component scale. The scores range from Level 1 to Level 5, with lower scores indicating a higher quality of life. This will be collected every 3 months and compiled at the end of the study to provide overall change in measurement.
Changes in patients' emPHasis-10 scores
时间窗: Baseline to end of the study, an average of 5 years
Assessed by the emPHasis-10 (pulmonary hypertension) instrument, which is an instrument specifically designed to assess the quality of life in patients with pulmonary hypertension. Each item will be scored from 0 to 5 where 0 was the best score. This will be collected every 3 months and compiled at the end of the study to assess overall change in measurement.
次要结局
- Changes in CTEPH-/CTED- specific medication(Baseline to end of the study, an average of 5 years)
- History of undergoing pulmonary endarterectomy(Through study completion, an average of 5 years)
- History of undergoing pulmonary balloon angioplasty(Through study completion, an average of 5 years)