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Clinical Trials/NCT02388867
NCT02388867
Completed
Not Applicable

Predictive Role of Matrix Metalloproteinases for the Outcome of Surgical Revascularization in Patients With Critical Limb Ischemia

University of Catanzaro0 sites30 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Limb Ischemia
Sponsor
University of Catanzaro
Enrollment
30
Primary Endpoint
MMPs evaluation
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

In the present study the investigators will evaluate MMPs. serum levels variations in patients affected by critical limb ischemia, before and after lower limb surgical revascularization through venous or prosthetic bypass.

Detailed Description

Recent clinical studies showed an association between Peripheral Artery Disease (PAD) and circulating levels of Matrix Metalloproteinases (MMPs), especially MMP-2, MMP-9, MMP-8 and MMP-10, compared with healthy controls. A recent study showed the association between MMP-10 serum levels and severity and poor outcome in patients affected by Critical Limb Ischemia (CLI). Also, MMPs seems to be involved in intimal hyperplasia and constrictive remodeling, both responsible of restenosis after surgical treatment of atherosclerotic lesions. Intimal hyperplasia is a thickening of the tunica intima resulting in narrowing of the vessel lumen. Elevated tissue levels of MMP-2 and MMP-9 have been identified in pig models of vein bypass grafts, temporally coinciding with the period of Smooth Muscle Cells (SMC) migration and neointimal formation. In the present study the investigators want to evaluate MMP-1; MMP-2, MMP-9, MMP-8 and MMP-10 serum levels variations in patients affected CLI, before and after lower limb surgical revascularization through venous or prosthetic bypass in order to assess their role in predicting the surgical outcome of these procedures. Patients with CLI will be randomized to receive lower limb surgical revascularization through autogenous venous (Group I) or prosthetic bypass (using synthetic polytetrafluoroethylene - PTFE- ) (Group II). Patients enrolled in the present study will be followed through clinical and ultrasonographic examination at 1, 3, 6, 12 and 24 months. At the same time points MMPs plasma levels (by means of blood sampling through venipuncture) will be evaluated. Clinical, Instrumental and Laboratory data then will be matched.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
March 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Catanzaro
Responsible Party
Principal Investigator
Principal Investigator

Prof. Raffaele Serra, MD, Ph.D.

Prof. Raffaele Serra

University of Catanzaro

Eligibility Criteria

Inclusion Criteria

  • patients with CLI stage III-IV according to the Fontaine's classification

Exclusion Criteria

  • Patients with evidence of systemic sepsis, known neoplastic disease or any established generalized inflammatory disease

Outcomes

Primary Outcomes

MMPs evaluation

Time Frame: 24 months

MMPs plasma levels will be evaluated during follow up.

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