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临床试验/NCT06081881
NCT06081881招募中不适用

Predictors for Chronic Thromboembolic Pulmonary Hypertension After Pulmonary Embolism Episode

Ester Ashraf Faried Beshay1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Incidence of CTEHP in symptomatic patients after pulmonary embolism episode.

研究概览

简要总结

to detect the incidence of CTEPH patients.

Primary outcome To predict CETHP in symptomatic patients after pulmonary embolism episode.

Secondary outcome:

On Echocardiography revealed RV dysfunction which are peak TR Velocity , the RV/LV basal diameter ratio, flattening of the IVS, RV acceleration time and/or midsystolic notching, IVC diameter with decreased inspiratory collapse and RA area.

详细描述

Chronic thrombo embolic pulmonary hypertension(CTEPH)is a progressive pulmonary vascular disease characterized by chronic obstruction of major pulmonary arteries with flow-limiting organized thrombi. In the clinical classification of the 6thWorld Symposium on Pulmonary Hypertension, CTEPH/chronic thromboembolic pulmonary disease(CTED)are in group4, labeled as PH due to pulmonary artery obstruction. CTEPH should be considered in PE patients if:(1)they report symptoms that could be related to CTEPH or with frank right heart failure,(2)the CTPA used to diagnose acute PE shows signs indicative of CTEPH,(3)they have risk factors or predisposing conditions for CTEPH. Recurrent venous thromboembolism(VTE),post-thrombotic syndrome, bleeding ,and functional limitations as important outcome measures of acute PE treatment , Dyspnea ,anxiety, chest pain ,post-thrombotic panic syndrome, and depression that lead to persistent functional limitations and/or decreased quality of life have been labeled as post-PE syndrome(PPS),includes CTEPH. Early diagnosis of CTEPH is important ,as it is the only form of PH that is potentially curable , but also challenging because signs of right heart failure only become evident in advanced disease stages and earlier disease stages are characterized by non specific or even absence of symptoms. The diagnostic work up of suspected CTEPH ,starts with trans thoracic Doppler echocardiography, In addition to the peak tricuspid regurgitation velocity , the right ventricle/left ventricle basal diameter ratio, flattening of the interventricular septum, right ventricular acceleration time and/or mid systolic notching, inferior vena cava diameter with decreased inspiratory collapse and right atrial area are used echocardiographic signs to assess the probability of PH.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient diagnosed as acute pulmonary embolism ,aged between 18-80 years old which Pulmonary Embolism Severity Index (PESI) class III-V or sPESI ≥1,

排除标准

  • Secondary causes for pulmonary hypertension Severe kidney injury(eGFR>30 mg/dl/1.7m2) Hepatic affection Contraindication to anti-coagulation

结局指标

主要结局

Incidence of CTEHP in symptomatic patients after pulmonary embolism episode.

时间窗: 3 years

Incidence of CTEHP in symptomatic patients after pulmonary embolism episode.

次要结局

  • Measure of RV dysfunction by Echocardiography(3 years)

研究者

发起方
Ester Ashraf Faried Beshay
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ester Ashraf Faried Beshay

Physician Resident

Assiut University

研究点 (1)

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