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Pathology, Venous Disease, and Clinical Correlations (PAVEDI)

2020年6月15日 更新者:Prof. Raffaele Serra, MD, Ph.D.、University of Catanzaro

Clinical and Pathological Correlations in Chronic Venous Disease

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (预期的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Catanzaro、意大利、88100
        • 招聘中
        • CIFL- Interuniversity Center of Phlebolymphology
      • Catanzaro、意大利、88100
        • 招聘中
        • University Magna Graecia of Catanzaro

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with varicose veins that are scheduled to undergo surgery for varicose veins removal.

描述

Inclusion Criteria:

  • Patients with varicose veins scheduled for surgery

Exclusion Criteria:

  • Peripheral artery disease
  • Malignancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:横截面

队列和干预

团体/队列
干预/治疗
Patients with varicose veins
Patients with varicose veins and eligible to receive open surgery (stab avulsion of varicose veins) as routinely care.
Stab avulsion is a technique to remove varicose veins. In this procedure, several tiny cuts (incisions) are made in the skin through which the varicosed vein is removed. Removed varicose veins will be collected and analyzed.
其他名称:
  • Phlebectomy
Sample obtained from varicose veins of lower limbs of patients will be collected and immediately fixed in formalin. The tissue fragments will be taken from varicose veins. Subsequently the tissue will be embedded in paraffin and 3-to-4 mm thick sections will be prepared by a microtome. The tissue sections will be processed for histological and immunohistochemical studies of VEGF, MM9, PGP 9.5 AND FRIBRONECTIN. For antibodies the EnVision staining system (Dako EnVision™) will be used. For the analysis of the positive structures detected by immunohistochemistry, a semiquantitative evaluation method will be used.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Expression of Matrix Metalloproteinase-9 (MMP-9)
大体时间: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).
at 10 month
Expression of Vascular Endothelial Growth Factor (VEGF)
大体时间: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).
at 10 month
Expression of Fibronectin
大体时间: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.
at 10 month
Expression of Protein Gene Product 9.5 (PGP 9.5)
大体时间: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
at 10 month

次要结果测量

结果测量
措施说明
大体时间
Correlation of the biomarkers expression with signs and symptoms
大体时间:At 11 month.
The expression of the biomarkers that will be studied on venous tissue samples will be correlated with the type of signs and symptoms complained by the patients.
At 11 month.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年12月1日

初级完成 (预期的)

2020年9月1日

研究完成 (预期的)

2020年10月1日

研究注册日期

首次提交

2020年6月15日

首先提交符合 QC 标准的

2020年6月15日

首次发布 (实际的)

2020年6月18日

研究记录更新

最后更新发布 (实际的)

2020年6月18日

上次提交的符合 QC 标准的更新

2020年6月15日

最后验证

2020年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ER.ALL.2018.11

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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