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临床试验/NCT04436549
NCT04436549Unknown不适用

Clinical and Pathological Correlations in Chronic Venous Disease

University of Catanzaro2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Expression of Fibronectin

研究概览

简要总结

Chronic Venous Disease (CVD) has a high prevalence in the general population of the western world. Varicose veins are the main signs of this disease that are characterized by important pathological vessel wall changes. There are also several symptoms that affect the quality of life of affected patients. The aim of this study is to correlate the main histopathological abnormalities with the type and the intensity of the symptoms.

详细描述

Chronic Venous Disease (CVD) of the lower limbs is a widespread chronic condition of the western world. There are several signs and symptoms that affect quality of life of patients with CVD. One of the main signs of this disease are varicose veins that are enlarged, swollen, and twisting superficial veins. Vessel wall of varicose veins shows a significant histopathological phenotype, characterized by a distortion of structural architecture: endothelial damage, disorganization of muscle bundles and alteration of the composition of the extracellular matrix (ECM). Symptoms may be different, according to disease state, progression and local inflammatory processes. To date, there is no study that correlate the type and the intensity of symptoms with histopathological phenotype.

Aim of this study is to correlate histopathological phenotype with clinical manifestations.

A cohort of patients with varicose veins scheduled for open surgical treatment that will undergo to stab avulsion of varicose veins will be recruited. Subsequently, venous tissue from stab avulsion will collected in order to evaluate the following biomarkers: VEGF (Vascular -Endothelial Growth Factor), PGP 9.5 (Protein Gene Product 9.5), Fibronectin and Matrix Metalloproteinase- 9 (MMP-9).

VEGF has a key role as a regulator of angiogenesis; its expression is highly regulated by hypoxia, in this case induced by venous hypertension. In addition to being a marker of neoangiogenesis, it increases vascular permeability in inflammatory disorders. PGP 9.5 is a marker of the innervation of the vessel wall that plays an important role in the regulation of venous tone. Fibronectin and MMP-9 are direct markers of ECM remodeling and impairment and they have also a role in chronic inflammation.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patients with varicose veins scheduled for surgery

排除标准

  • Peripheral artery disease
  • Malignancy

结局指标

主要结局

Expression of Fibronectin

时间窗: at 10 month

EnVision staining system (Dako EnVision™) will be used. A synthetic peptide made toward the C-terminal region of the human Fibronectin protein (within residues 2250-2300) will be used with dilution 1:400 citrate buffer.

Expression of Matrix Metalloproteinase-9 (MMP-9)

时间窗: at 10 month

EnVision staining system (Dako EnVision™) will be used. A synthetic peptide from the middle region of human MMP9 will be used with dilutions 1:50 with Ethylenediaminetetraacetic acid (EDTA).

Expression of Vascular Endothelial Growth Factor (VEGF)

时间窗: at 10 month

EnVision staining system (Dako EnVision™) will be used. Monoclonal mouse Anti-Human vascular endothelial growth factor, code No. M7273 will be used with dilution 1:50 with Ethylenediaminetetraacetic acid (EDTA).

Expression of Protein Gene Product 9.5 (PGP 9.5)

时间窗: at 10 month

EnVision staining system (Dako EnVision™) will be used. Purified PGP 9.5 isolated from bovine brain will be used with dilution 1:200 citrate buffer

次要结局

  • Correlation of the biomarkers expression with signs and symptoms(At 11 month.)

研究者

发起方
University of Catanzaro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Raffaele Serra, MD, Ph.D.

Associate Professor of Vascular Surgery

University of Catanzaro

研究点 (2)

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