Evaluation of Plasma and Tissue Levels of Metalloproteinases and Neutrophil Gelatinase-associated Lipocalin in Arterial Aneurysms.
Sponsor study identifier
observational
307
1 country
1
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
March 2014
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
December 2013
Actual (reported)March 2014
Actual (reported)May 19, 2014
Actual (reported)May 23, 2014
Actual (reported)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
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
patient with ruptured aneurysms
patients with non-ruptured aneurysms
Healthy volunteers
Patients with diagnosis of aneurysmal disease (central and peripheral, ruptured and non-ruptured).
University of Catanzaro
Catanzaro, 88100, Italy
Stefano de Franciscis, M.D.
University Magna Graecia of Catanzaro
Raffaele Serra
University Magna Graecia of Catanzaro
307 participants (actual enrollment reported by the registry).
First Submitted
May 19, 2014
First Posted
May 23, 2014
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
December 2013
Actual (reported)Study Completion
March 2014
Actual (reported)Last Updated
May 23, 2014
Record last verified: 2014-05
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