Matrix Metalloproteinases in Patients With Critical Limb Ischemia Undergoing Surgical Revascularization

Not Applicable

Completed

• Conditions: Peripheral Revascularisation; Critical Limb Ischemia; Extracellular Matrix Alteration
• Interventions: Procedure: Polytetrafluoroethylene (PTFE) bypass grafting.; Procedure: Autogenous vein bypass grafting

• Registration Number: NCT02388867
• Lead Sponsor: University of Catanzaro

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2015-01
• Status Verified: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-13
• Last Update Submitted: 2015-03-13
• Study First Posted: 2015-03-17
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Polytetrafluoroethylene (PTFE) bypass grafting.	Intervention: Polytetrafluoroethylene (PTFE) bypass grafting.
Group II	Autogenous vein bypass grafting	Intervention: Autogenous vein bypass grafting.

Primary Outcome Measures

Name	Time	Method
MMPs evaluation	24 months	MMPs plasma levels will be evaluated during follow up.