Serum Levels of Klotho as a Possible Biomarker of Peripheral Artery Disease

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05757271

Collaborator

(none)

207

Enrollment

Location

48.3

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Klotho, a membrane-bound protein co-receptor for fibroblast growth factor 23 (FGF23), is involved in atherosclerotic process and cardiovascular diseases. It regulates blood glucose and cholesterol levels. In addition, the lack of klotho has been associated with endothelial dysfunction, calcification and accumulation of cholesterol in the arteries, leading to coronary heart disease.

The goal of this observational study is to evaluate the potential use of circulating klotho and FGF23 serum levels as biomarkers of major adverse limb events (MALE) and major adverse cardiovascular events (MACE) in patients with peripheral artery disease (PAD) and chronic limb threatening ischemia (CLTI) requiring a procedure of endovascular revascularization.

The main questions it aims to answer are:

association between klotho and FGF23 serum levels and major adverse limb events (MALE) after lower extremity revascularization.
association between klotho and FGF23 serum levels and major adverse cardiovascular events (MACE) after lower extremity revascularization.

Patients with PAD and CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating klotho and FGF23 before the endovascular procedure.

Incidence of MACE and MALE will be collected in a 12-months follow-up and will be associated with klotho and FGF23 serum levels at baseline.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

207 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Serum Levels of Klotho as a Possible Biomarker of Peripheral Artery Disease Progression

Actual Study Start Date :

Oct 23, 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 klotho and FGF23 serum levels [12-months follow-up]
To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and MALE during the follow-up period.

Secondary Outcome Measures

Association between incidence of myocardial infarction and klotho and FGF23 serum levels [12-months follow-up]
To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and myocardial infarction during the follow-up period.
Association between incidence of stroke and klotho and FGF23 serum levels [12-months follow-up]
To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and stroke during the follow-up period.
Association between incidence of cardiovascular death and klotho and FGF23 serum levels [12-months follow-up]
To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and cardiovascular death during the follow-up period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age of at least 40 years
Ankle/Brachial Index (ABI) of less than 80
at least one lower limb stenosis greater than 50% documented by Ultrasound Color Doppler (US)
stage 4 or 5 PAD diagnosis according to the Rutherford classification
presence of chronic limb threatening ischemia
indication for LER of the target arterial stenosis