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

NCT05757271 | Unknown

• 1 other identifier: 2753
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Klotho; FGF23; MALE; MACE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Association between incidence of myocardial infarction and klotho and FGF23 serum levels

  12-months follow-up

• Association between incidence of stroke and klotho and FGF23 serum levels

  12-months follow-up

• Association between incidence of cardiovascular death and klotho and FGF23 serum levels

  12-months follow-up

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will enroll consecutive subjects with PAD and CLTI requiring for endovascular revascularization and admitted to Internal Medicine Cardiovascular Unit of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Flex Andrea, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flex Andrea, MD, PhD

CONTACT

+39 06 3015 4293; andrea.flex@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: October 23, 2019
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-02

Locations

IT (1)