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

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral Arterial Disease

Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: pregnancy acute infections at present or in the previous month primary hyperparathyroidism revascularization of the lower limb in the previous 3 months diabetic foot ulcers with signs of active infection or osteomyelitis diabetic peripheral neuropathy homozygous familial hypercholesterolemia absolute contraindication to antiplatelet therapy thrombophilia active cancer active autoimmune disease liver disease at functional status B or C according to Child-Pugh contraindication to endovascular revascularization organ transplantation

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between incidence of MALE and klotho and FGF23 serum levels | To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and MALE during the follow-up period. | 12-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between incidence of myocardial infarction and klotho and FGF23 serum levels | To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and myocardial infarction during the follow-up period. | 12-months follow-up | 
| Association between incidence of stroke and klotho and FGF23 serum levels | To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and stroke during the follow-up period. | 12-months follow-up | 
| Association between incidence of cardiovascular death and klotho and FGF23 serum levels | To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and cardiovascular death during the follow-up period. | 12-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Klotho, FGF23, MALE, MACE