Serum Levels of Klotho as a Possible Biomarker of Peripheral Artery Disease Progression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Association between incidence of MALE and klotho and FGF23 serum levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Association between incidence of MALE and klotho and FGF23 serum levels
时间窗: 12-months follow-up
To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and MALE during the follow-up period.
次要结局
- 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)
研究者
Flex Andrea
MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS