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临床试验/NCT06550648
NCT06550648已完成不适用

Evaluation of the Role of Epstein-Bar Virus in Patients With Pulmonary Arterial Hypertension

Cairo University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
The presence of EBV within the endothelial cell line in patients

研究概览

简要总结

Evaluate the role of Epstein-Barr virus infection in PAH (Idiopathic and connective tissue disease).

This by obtaining a blood sample from the PAH patients undergoing right heart cathetrization as well as obtaining the endothelial cells from the balloon tipped catheters and extracting the EBV virus to detect its presence.

IgG, IgM and PCR for EBV tests will be done.

详细描述

About Pulmonary Hypertension Pulmonary hypertension (PH) is a pathophysiological disorder that may involve multiple clinical conditions combined with a variety of cardiovascular and respiratory diseases. It is defined by a mean pulmonary arterial pressure (mPAP) of more than 20 mmHg at rest (Humbert, M.et al., 2022).

Pulmonary arterial hypertension (PAH) is a condition characterized by vascular proliferation, leading to increased vascular resistance and right heart dysfunction. PAH may be idiopathic (Idiopathic Pulmonary Arterial Hypertension IPAH; previously known as primary pulmonary hypertension, PPH) or associated with other conditions or exposures, including connective tissue diseases, HIV infection, portal hypertension, and anorexigenic drug ingestion (Humbert, M.et al., 2022).

About Chronic active Epstein-Barr virus Chronic Active Epstein-Barr virus (CAEBV) disease is usually defined as a chronic illness lasting at least 6 months, an increased EBV level in either the tissue or the blood, and lack of evidence of a known underlying immunodeficiency. It may be associated with Burkitt lymphoma and nasopharyngeal carcinoma, Hodgkin lymphoma, peripheral T cell lymphoma, angioimmunoblastic T cell lymphoma, and extranodal NK/T cell lymphoma (Kimura et al., 2017).

CAEBV is characterized by an unusual pattern of anti-EBV antibodies and may be associated with cardiovascular abnormalities (Hashimoto et al., 2011).

Diagnosis of Epstein-Barr virus (EBV) infection is based on clinical symptoms and serological markers, including the following: immunoglobulin G (IgG) and IgM antibodies to the viral capsid antigen (VCA), heterophile antibodies, and IgG antibodies to the EBV early antigen-diffuse (EA-D) and nuclear antigen (EBNA-1)(Klutts JS. Et al., 2009).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Group 1 PAH (Idiopathic ) Group 1 PAH ( Connective tissue disease including SLE, Systemic sclerosis and mixed connective tissue disease) Above 18 years

排除标准

  • Other Groups of Pulmonary hypertension Patients refusing written consent or participation

结局指标

主要结局

The presence of EBV within the endothelial cell line in patients

时间窗: from may 2023 till july 2024

PCR of the virus in the endothelial cell culture proving the viral invasion causing the remodeling

EBV PCR and Immunoglobulins in patients with PAH test will be done

时间窗: from may 2023 till july 2024

by virus detection in both blood and endothelial cells and its immunoglobulins

The percentage of EBV-positive patients to normal control subjects

时间窗: from may 2023 till july 2024

Test results statically analyzed to corelate

次要结局

  • CAEBV-infected individual 's risk assessment compared to the risk assessment of those who are not infected.(from may 2023 till july 2024)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Yasser Mohammed Elhalafawy

Dr

Cairo University

研究点 (1)

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