Symptom-related Screening Program Following Pulmonary Embolism for Early Detection of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 646
- 试验地点
- 16
- 主要终点
- Number of new diagnosis of CTEPH
研究概览
简要总结
Routine screening for Chronic thromboembolic pulmonary hypertension (CTEPH) i after PE is not supported by current evidence and guidelines.
This study aims to evaluate if a screening program for patients with acute PE based on telephone monitoring of symptoms and further examination if only symptomatic patients could help an early detection of CTEPH.
详细描述
Chronic thromboembolic pulmonary hypertension (CTEPH) is a long-term complication following an acute or silent pulmonary embolism (PE). A history of acute PE was reported in 75% of CTEPH patients. Nevertheless, incidence of CTEPH after a confirmed acute PE vary widely depending of the studies, with estimated incidence from 0.5 to 4%. Performing a follow-up examination of patients diagnosed with acute PE regardless of persisting symptoms and using all available technical procedures is not cost-effective. As a consequence, routine screening for CTEPH after PE is not supported by current evidence and guidelines.
CTEPH is a very disabling and mortal disease, although it is a potential curable disease. However, delayed diagnosis and misdiagnosis is common. Patients are frequently diagnosed with CTEPH at advanced stages of the disease leading to worse clinical outcomes. Early diagnosis of CTEPH is essential, as delay in diagnosis may be associated with a worse prognosis, higher perioperative mortality and inoperable diseases stages. Overall, evidence from various sources suggests that early detection and treatment of CTEPH is advantageous in achieving favorable clinical outcomes. Therefore, there is an important unmet need for early diagnosing this disease.
Focusing diagnostic procedures only on symptomatic patients may be a practical approach for detecting relevant CTEPH.
This study aims to evaluate if a screening program for patients with acute PE based on telephone monitoring of symptoms and further examination if only symptomatic patients could help an early detection of CTEPH.
Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 > 18 year
- •Objectively confirmed diagnosis of acute PE by multidetector CT, V/Q lung scan, or selective pulmonary angiography, according to established diagnostic criteria, with or without symptomatic DVT,
- •Ability of subject to understand the character and consequences of the study,
- •informed consent of the subject.
排除标准
- •refused informed consent, inability to cooperation.
研究组 & 干预措施
Screening
Intervention Investigator from each center will recover consecutives PE patients and collect baseline, demographic and comorbidities.
In all patients enrolled in the study a short questionnaire regarding dyspnea symptoms will be performed. All patients that refer dyspnea grade ≥ II according NYHA-WHO (6) modified scale will be cited as outpatient to be evaluated Imaging studies and right heart catheterization is the procedure agreeing with the standard care according to current ESC/ERS Guidelines.
In all patients, the following tests will be performed:
- Pulsioximetry.
- Electrocardiogram.
- Blood sample with determination of NT-ProBNP.
- Echocardiography. Only an echocardiography indicative of PH warrants further evaluation
- V/Q scintigraphy. Possible CTEPH can be assumed when mismatched perfusion defects are detected by VQ scan.
- Right heart catheterization & Pulmonary CT Scan are required for confirming the diagnosis
干预措施: dyspnea grade ≥ II according NYHA-WHO (Diagnostic Test)
结局指标
主要结局
Number of new diagnosis of CTEPH
时间窗: Up 3 years after PE
New diagnosis of CTEPH
次要结局
- Derivation of a score to identify high risk population to develop CTEPH(Up 3 years after PE)
- External validation from score to identify patients at risk to develop CTEPH(Up 3 years after PE)
- Number of patients with Chronic Thromboembolic Disease (CTED) after PE(Up 3 years after PE)
研究者
Luis Jara-Palomares, MD
Principal Investigator
Hospitales Universitarios Virgen del Rocío