Early Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients After Acute Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 10
- 主要终点
- Positive predictive value of initial examination
研究概览
简要总结
The project is a national, prospective, multicenter, observational pilot project of screening CTEPH in pacients after APE in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Chronic tromboembolic pulmonary hypertesion in such a way as to ensure the maximum positive impact on the health of the population and high cost-effectiveness of the whole process.
详细描述
The project is a national, prospective, multicenter, observational pilot project of screening CTEPH in pacients after APE in the Czech Republic.
The global goal of the project is to develop, test and implement a uniform procedure for early detection of patients with CTEPH and to set up a process for their rapid referral to a specialized center that treats chronic thromboembolic pulmonary hypertension. The timeliness of the treatment set up has a significant impact on patient's future quality of life and eliminates the risk of subsequent complications or death.
The main objective of this activity is to validate the CTEPH screening process, which will benefit 500 patients in approximately 10 selected centres. Subsequently, patient flow from the cardiologist to a specialised pulmonary hypertension treatment centre will be ensured. The process will include a review and evaluation of the screening algorithm in patients in the pilot.
The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002007
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
- •Age over 18 years
- •Signed consent to participate in the project and GDPR
- •Patients with an episode of acute pulmonary embolism in the last 3-12 months, with ongoing anticoagulation therapy:
- •Patients with new-onset and ongoing or progressive dyspnea (min. NYHA II) after a pulmonary embolism episode or worsening of dyspnea after a pulmonary embolism episode compared to the status before the episode (at least 1 HYHA grade) or
- •Asymptomatic patients after a pulmonary embolism episode and at least one of the following risk factors:
- •ECHO evidence of severe PH at diagnosis of PE (PASP >60 mmHg)
- •Antiphospholipid syndrome with triple positivity (presence of lupus anticoagulans + anti-beta-2-glycoprotein I (B2GPI) antibodies + anticardiolipin)
- •Infected permanent venous inlets and cardiac pacing/defibrillation intravascular systems
- •Presence of ventriculoatrial shunt for treatment of hydrocephalus
- •Nonspecific intestinal inflammation (ulcerative colitis, Crohn's disease)
- •History of splenectomy
- •Myeloproliferative disorders
- •Chronic osteomyelitis
排除标准
- •Not agreeing to participate in the project
- •Contraindications to treatment
结局指标
主要结局
Positive predictive value of initial examination
时间窗: Up to six months from enrollment
Examinations include echocardiography, CT scan or scintigraphy, and possibly other examinations determined by the cardiologist. Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the primary detection site.
CTEPH detection rates
时间窗: Up to six months from enrollment
Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the specialized centre.
Proportion of people with suspected CTEPH who attended a follow-up examination at a specialized pulmonary hypertension treatment centre
时间窗: Up to six months from enrollment
Examinations include echocardiography, CT scan or scintigraphy, and possibly other examinations determined by the cardiologist. Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the primary detection site.
次要结局
未报告次要终点