Gut Microbiota and Failure of Endovascular Revascularization in Diabetic Patients With Peripheral Arterial Disease and Chronic Limb-threatening Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Association between incidence of MALE and gut microbiota and TMAO serum levels
研究概览
简要总结
Microbiota has been associated with risk factors for cardiovascular diseases (hypertension, obesity, dyslipidemia, diabetes mellitus, heart failure). In animal models, the gut microbiota produces pro-inflammatory proteoglycans that increase the extent of myocardial infarction, reduced by treatment with probiotics (Lactobacillus). TMAO, a blood metabolite directly dependent on the gut microbiota is related to atherosclerotic plaque instability and major adverse cardiovascular events (MACE) in humans. Recent data demonstrate that blood levels of TMAO directly correlate with the risk of major MACE and mortality in patients with peripheral arterial disease (PAD).
The goal of this observational study is to evaluate the association between gut microbiota and TMAO serum levels and MACE and major adverse limb events (MALE) in 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 gut microbiota and TMAO serum levels and MALE after lower extremity revascularization.
- association between gut microbiota and TMAO serum levels and MACE after lower extremity revascularization.
Patients with CLTI requiring lower extremity endovascular revascularization will undergo stool sampling for determination of gut microbiota and blood sampling for the dosage of circulating TMAO before the endovascular procedure.
Incidence of MALE and MACE will be collected in a 24-months follow-up and will be associated with gut microbiota and TMAO serum levels.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of at least 18 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
- •acute infections at present or in the previous month
- •antibiotic treatment 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
- •organ transplantation
- •active cancer
- •liver disease at functional status B or C according to Child-Pugh
- •absolute contraindication to antiplatelet therapy
- •thrombophilia
- •contraindication to endovascular revascularization
结局指标
主要结局
Association between incidence of MALE and gut microbiota and TMAO serum levels
时间窗: 24-months follow-up
To evaluate the association between gut microbiota and TMAO serum levels before endovascular revascularization and incidence of MALE during the follow-up period.
次要结局
- Association between incidence of stroke and gut microbiota and TMAO serum levels(24-months follow-up)
- Association between incidence of cardiovascular death and gut microbiota and TMAO serum levels(24-months follow-up)
- Association between incidence of myocardial infarction and gut microbiota and TMAO serum levels(24-months follow-up)
研究者
Flex Andrea
MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS