Matrix Metalloproteinases (MMPs),Neutrophil Gelatinase-associated Lipocalin (NGAL) Tissue and Plasma Levels and Aneurysms

MMPs and NGAL in Ruptured and Non-ruptured Aneurysms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145533
• Other study ID #: SURVAS
• Status: Completed
• Phase: N/A
• First received: May 19, 2014
• Last updated: May 22, 2014
• Start date: January 2010
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: University of Cantanzaro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with the diagnosis of arterial aneurysmal disease

Exclusion Criteria:

• History of cancer

• Hepatic failure

• Infectious or autoimmune diseases

• Patients requiring endovascular treatment.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• MMPs and NGAL in Ruptured and Non-ruptured Aneurysms

Locations

Country	Name	City	State
Italy	University of Catanzaro	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Cantanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of MMPs levels in ruptured and non-ruptured aneurysms	MMPs plasma levels are evaluated via ELISA test. MMPs tissue levels are evaluated via Immunoblotting using anti MMPs monoclonal antibodies	52 months	No
Primary	Evaluation of NGAL levels in ruptured and non-ruptured aneurysms	NGAL plasma levels are evaluated via ELISA test. NGAL tissue levels are evaluated via Immunoblotting using anti NGAL monoclonal antibodies	52 months	No