跳至主要内容
临床试验/NCT03061487
NCT03061487Unknown不适用

The Influence of Statin Treatment on Aneurysmatic Disease

University of Catanzaro1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年2月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Evaluation of MMP-2, MMP-9 and NGAL levels in blood and aneurysms tissue

研究概览

简要总结

The altered balance between the proteinases and their tissue inhibitors (TIMPS) is one of the pathogenetical mechanism of the aneurysmatic connective tissue degeneration. The increasement of protease, collagenase and elastase activity results indeed in a dramatic drop of collagen and elastin tissue and serum levels.Matrix Metalloproteinases (MMPs) are a group of proteolytic enzymes that along with their specific and non-specific inhibitors modulate the extracellular matrix composition. Recent studies have suggested an interesting role of microRNAs (miRNAs) in the regulation mechanisms of inflammation.

The aim of our study is to analyse the influence of statin treatment on aneurysmatic disease by monitoring MMPs and miRNAs in aneurysmatic wall tissue and MMps blood levels.

详细描述

The altered balance between the proteinases and their tissue inhibitors (TIMPS) is one of the pathogenetical mechanism of the aneurysmal connective tissue degeneration. The increase of protease, collagenase and elastase activity results indeed in a dramatic drop of collagen and elastin tissue and serum levels.

Vessels wall strength decrease is associated with the blood flow shear stress and affects negatively the walls integrity, causing the aneurysmatic vessel degeneration.

Matrix Metalloproteinases (MMPs) are a group of proteolytic enzymes that along with their specific and non-specific inhibitors modulate the extracellular matrix composition.

So far, 25 MMPs have been discovered, in particular, the ones that will be considered in this study are: MMP-2, MMP-9, and neutrophil gelatinase-associated lipocalin (NGAL) a related protein which is able to control MMP-9 activities.

Inflammation plays a central role in the pathogenetical pathway of aneurysmatic developement. Recent studies have suggested an interesting role of miRNAs in the regulation mechanisms of inflammation. miRNAs are short ribonucleic acid molecules usually composed of 20 to 25 nucleotides that can regulate mRNA transcription and protein translation by targeting the 3'-untranslated regions (3'-UTR) of target genes. miRNAs are involved in various physiological responses and pathological processes. Increasing evidence suggest that miRNAs are involved in inflammatory responses. In particular the ones that will be focused on this study are: miR-29b, miR-21, miR-181a, miR-150.

研究设计

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

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 under statins treatment with pleiotropic effect: Simvastatin, Rosuvastatin, Atorvastatin
  • Patients underwent open aneurysm repair
  • signing informed consent

排除标准

  • Patients with chronic diseases such as liver diseases
  • Pazient whith malignant diseases
  • Recreational drug intake and alcohol abuse
  • Intake of statins other than those under study or in combination therapy

结局指标

主要结局

Evaluation of MMP-2, MMP-9 and NGAL levels in blood and aneurysms tissue

时间窗: 1 year

MMP-2, MMP-9 and NGAL will be studied in both groups. Elisa Testing will be used to analyze the blood samples and Western blot analysis will be used for the tissue samples.

Evalutation of miRNAs levels in blood and aneurysms tissue

时间窗: 1 year

Evaluation of miRNAs levels (in particular miR29b, miR-181a, miR-21, miR-150) will be studied in both groups. Stem-loop reverse-transcription PCR (RT-qPCR) method will be used for measuring individual microRNAs (miRNAs) in tissue and blood samples.

次要结局

未报告次要终点

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 (1)

Loading locations...

相似试验