Matrix Metalloproteinases in Patients With Critical Limb Ischemia Undergoing Surgical Revascularization

NCT ID: NCT02388867

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-03-31

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.

Conditions

Critical Limb Ischemia; Extracellular Matrix Alteration; Peripheral Revascularisation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group I

Intervention: Polytetrafluoroethylene (PTFE) bypass grafting.

Group Type: EXPERIMENTAL

Polytetrafluoroethylene (PTFE) bypass grafting.

Intervention Type: PROCEDURE

Polytetrafluoroethylene (PTFE) bypass grafting. Patients will undergo bypass procedure using PTFE graft : the inflow vessel may be the femoral artery or the iliac artery; the outflow vessel may be the popliteal artery or the anterior tibial artery.

Group II

Intervention: Autogenous vein bypass grafting.

Group Type: EXPERIMENTAL

Autogenous vein bypass grafting

Intervention Type: PROCEDURE

Autogenous vein bypass grafting. Patients will undergo Bypass procedure using autogenous veins (the great saphenous vein or the small saphenous vein or a composite bypass using great and small saphenous vein ). The inflow vessel may be represented by the femoral artery or the popliteal artery; the outflow vessel may be the anterior tibial artery or the posterior tibial artery or the peroneal artery.

Interventions

Polytetrafluoroethylene (PTFE) bypass grafting.

Polytetrafluoroethylene (PTFE) bypass grafting. Patients will undergo bypass procedure using PTFE graft : the inflow vessel may be the femoral artery or the iliac artery; the outflow vessel may be the popliteal artery or the anterior tibial artery.

Intervention Type: PROCEDURE

Autogenous vein bypass grafting

Autogenous vein bypass grafting. Patients will undergo Bypass procedure using autogenous veins (the great saphenous vein or the small saphenous vein or a composite bypass using great and small saphenous vein ). The inflow vessel may be represented by the femoral artery or the popliteal artery; the outflow vessel may be the anterior tibial artery or the posterior tibial artery or the peroneal artery.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Catanzaro

OTHER

Sponsor Role: lead

Responsible Party

Prof. Raffaele Serra, MD, Ph.D.

Prof. Raffaele Serra

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ER.ALL.2014.10.A

Identifier Type: -

Identifier Source: org_study_id