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临床试验/NCT06463106
NCT06463106已完成不适用

Endothelial Dysfunction in Post-infection Fatigue Syndromes

FH Joanneum Gesellschaft mbH1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2021年6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
107
试验地点
1
主要终点
Endothelial permeability

研究概览

简要总结

Post-infection chronic fatigue syndromes, such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-COVID-19 condition (Long Covid), are conditions primarily characterized by debilitating fatigue. This fatigue can range from mild, where patients are still able to participate in some social activities (e.g., school, work), to moderate and severe, where sufferers are predominantly homebound and bedridden. As a result, ME/CFS and Long Covid not only negatively impact the quality of life of affected individuals and their caregivers but also represent a substantial and often silent burden on healthcare systems worldwide, including Austria. This is primarily because most cases remain undiagnosed due to the lack of standardized clinical assessments and diagnostic markers. Endothelial dysfunction, which is well known to affect blood flow, oxygen and nutrient delivery, and waste removal in the body, has been described as one of the key factors behind the symptoms experienced by ME/CFS and Long Covid patients. However, the mechanisms that might explain the development of endothelial dysfunction remain largely unexplored. Therefore, this project aims to evaluate key biological aspects related to the function of endothelial cells - a layer of cells lining blood vessels - using plasma samples from an Austrian cohort of ME/CFS and Long Covid patients. We expect that the findings from our study will provide new insights to better understand endothelial dysfunction in post-infection chronic fatigue syndromes, leading to improved patient stratification and tailored treatment alternatives.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria for ME/CFS patients not infected with SARS-CoV-2 (n=17; females: 70.59%; age (years): 40.10 ± 10.80) and Long-Covid patients (n=30; females: 73.4%; age (years): 37.70 ± 9.96) include profound fatigue and at least one of the following symptoms: PEM, autonomic dysfunction, and/or orthostatic intolerance. All participants were included only if they were at least 12 weeks past an acute EBV infection and/or 10 weeks past an acute SARS-CoV-2 infection, respectively. SARS-CoV-2 specific IgA (A) and IgG (B) antibody titers were measured using commercial test kits (Anti-SARS-CoV-2-ELISA (IgA) and Anti-SARS-CoV-2-QuantiVac-ELISA (IgG); Euroimmun, Germany) in plasma samples.

排除标准

  • Participants' exclusion criteria included evidence of acute malignant diseases, diabetes mellitus, acute sepsis, chronic inflammatory gastrointestinal diseases, and frequent intake of analgesics, antacids, or antibiotics. Furthermore, no previously hospitalized SARS-CoV-2 patients were included, eliminating false-positive fatigue due to intensive care treatment, such as artificial respiration.

结局指标

主要结局

Endothelial permeability

时间窗: 6 months

3D culture model

Circulating levels of L-arginine metabolites

时间窗: 6 months

Ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS)

Markers of endothelial inflammation

时间窗: 6 months

ELISA

Angiogenesis

时间窗: 6 months

3D culture model

Epigenetic and transcriptomic patterns in endothelial cells

时间窗: 6 months

Genome wide DNA methylation and RNA sequencing (RNA-seq)

Production of reactive oxygen species (ROS) in endothelial cells

时间窗: 6 months

Fluorometric assay

次要结局

未报告次要终点

研究者

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

Francisco Westermeier

PhD

FH Joanneum Gesellschaft mbH

研究点 (1)

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