Cardiovascular Biomarkers in Peripheral Artery Disease.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05757258

Collaborator

(none)

207

Enrollment

Location

48.2

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Despite the best medical management, many patients with peripheral artery disease (PAD) who undergo lower extremity endovascular revascularization experience adverse cardiovascular outcomes and postoperative complications that may increase the risk of acute limb ischemia or amputation. There are no clear molecular associations that could explain the differences in outcomes after endovascular therapy in patients with PAD. The variable outcomes following endovascular therapy may depend, at least in part, on the profile of cytokines involved in inflammatory and atherosclerotic processes.

The goal of this observational study is to evaluate the potential use of circulating IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 levels as biomarkers of major adverse limb events (MALE) and major adverse cardiovascular events (MACE) in diabetic patients with PAD and chronic limb-threatening ischemia (CLTI) requiring a procedure of endovascular revascularization.

The main questions it aims to answer are:

association between serum levels of IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 at baseline and major adverse limb events (MALE) after lower extremity revascularization.
association between serum levels of IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 at baseline and major adverse cardiovascular events (MACE) after lower extremity revascularization.

Diabetic patients with CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 before the endovascular procedure.

Incidence of MALE and MACE will be collected in a 12-months follow-up and will be associated with IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

207 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cardiovascular Biomarkers in Diabetic Patients Undergoing Endovascular Revascularization for Chronic Limb-threatening Ischemia (CLTI).

Actual Study Start Date :

Oct 24, 2019

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Outcome Measures

Primary Outcome Measures

Association between incidence of MALE and IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels [12-months follow-up]
To evaluate the association between IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels before endovascular revascularization and incidence of MALE during the follow-up period.

Secondary Outcome Measures

Association between incidence of myocardial infarction and IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels [12-months follow-up]
To evaluate the association between IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels before endovascular revascularization and incidence of myocardial infarction during the follow-up period.
Association between incidence of stroke and IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels [12-months follow-up]
To evaluate the association between IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels before endovascular revascularization and incidence of stroke during the follow-up period.
Association between incidence of cardiovascular death and IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels [12-months follow-up]
To evaluate the association between IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels before endovascular revascularization and incidence of cardiovascular death during the follow-up period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age of at least 18 years
diagnosis of T2DM present for a least one year
Ankle/Brachial Index (ABI) of less than 0.80
lower limb stenosis greater than 50% documented by Ultrasound Color Doppler (US)
category 4 or 5 of PAD in accordance with the Rutherford classification
presence of CLTI requiring endovascular treatment

Exclusion Criteria:

pregnancy
acute infections at present or in the previous month
diabetic foot ulcers with sign of infection or osteomyelitis
previous lower-limb endovascular or surgical revascularization within the past 3 months
diabetic peripheral neuropathy
liver disease with a functional status B or C in accord to Child-Pugh classification
congenital or acquired thrombophilia
active autoimmune disease
active cancer
organ transplantation
life expectancy < 12 months
contraindication to antiplatelet therapy
contraindication to endovascular revascularization