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临床试验/NCT02145533
NCT02145533已完成不适用

Evaluation of Plasma and Tissue Levels of Metalloproteinases and Neutrophil Gelatinase-associated Lipocalin in Arterial Aneurysms.

University of Catanzaro1 个研究点 分布在 1 个国家目标入组 307 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
307
试验地点
1
主要终点
Evaluation of MMPs levels in ruptured and non-ruptured aneurysms

研究概览

简要总结

An association between arterial aneurysms and matrix metalloproteinases (MMPs) has been described previously. MMPs regulate extracellular structural proteins and tissue remodeling. Neutrophil Gelatinase-associated Lipocalin (NGAL) is involved in the regulation of MMP activity. The aim of this work was to study the relationship between the levels of MMPs and NGAL and arterial aneurysms.

In a multicenter, open label, parallel groups, prospective study, patients with aneurysmal disease were divided into two groups: Group I (with ruptured aneurysm) and Group II (with non-ruptured aneurysm). Healthy volunteer patients were also enrolled and represented the control group (Group III).

The investigators enrolled 307 patients (Group I: 107, Group II: 200) with arterial aneurysm: 49 popliteal, 31 common femoral, 2 superficial femoral, 29 common iliac artery, 3 common carotid and 193 abdominal aorta. Finally, 11 healthy volunteer patients (9 males and 2 females, age range 40-70 year-old, median 56) were enrolled in Group III.

Elisa test and Western blot analysis revealed greater levels of immunoreactive MMP-9 and NGAL in all patients with ruptured aneurysms, both central and peripheral aneurysms, and in the aneurismal vessels.

These results provide important advances in the understanding of the natural history of arterial aneurysms. MMPs and NGAL play a role in development of arterial aneurysms and they may represent molecular markers for the prevention of aneurysmal rupture

详细描述

In the present study, the analysis of MMPs levels in plasma and tissues in patients with aneurysmal lesions identified several patterns of protease activity. Levels of both MMP-9 and NGAL were increased in aneurismal vessels, while the patterns of MMP-9 and NGAL expression was very high in all patients with ruptured aneurysm, both central and peripheral. These results show: 1) the chronic and degenerative nature of the aneurysmal lesion which is associated with increased levels of inflammatory proteinases, like MMP-9; 2) the apparent pivotal role of MMP-9 and NGAL in the pathophysiologic processes which lead to the final stage of natural history of aneurysms; and 3) the ubiquitous distribution of MMP-9 and NGAL. The pattern increased expression of MMP-9 and NGAL appears to be specific for aneurysmal arteries and it is not dependent on the anatomic site of the lesion.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with the diagnosis of arterial aneurysmal disease

排除标准

  • History of cancer
  • Hepatic failure
  • Infectious or autoimmune diseases
  • Patients requiring endovascular treatment.

结局指标

主要结局

Evaluation of MMPs levels in ruptured and non-ruptured aneurysms

时间窗: 52 months

MMPs plasma levels are evaluated via ELISA test. MMPs tissue levels are evaluated via Immunoblotting using anti MMPs monoclonal antibodies

Evaluation of NGAL levels in ruptured and non-ruptured aneurysms

时间窗: 52 months

NGAL plasma levels are evaluated via ELISA test. NGAL tissue levels are evaluated via Immunoblotting using anti NGAL monoclonal antibodies

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

Luca Gallelli

MD

University of Catanzaro

研究点 (1)

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