Gut Microbiota in Patients With Peripheral Arterial Disease and Chronic Limb-threatening Ischemia

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05757297

Collaborator

(none)

130

Enrollment

Location

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

130 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Gut Microbiota and Failure of Endovascular Revascularization in Diabetic Patients With Peripheral Arterial Disease and Chronic Limb-threatening Ischemia

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Oct 31, 2025

Outcome Measures

Primary Outcome Measures

Association between incidence of MALE and gut microbiota and TMAO serum levels [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.

Secondary Outcome Measures

Association between incidence of myocardial infarction and gut microbiota and TMAO serum levels [24-months follow-up]
To evaluate the association between gut microbiota and TMAO serum levels before endovascular revascularization and incidence of myocardial infarction during the follow-up period.
Association between incidence of stroke and gut microbiota and TMAO serum levels [24-months follow-up]
To evaluate the association between gut microbiota and TMAO serum levels before endovascular revascularization and incidence of stroke during the follow-up period.
Association between incidence of cardiovascular death and gut microbiota and TMAO serum levels [24-months follow-up]
To evaluate the association between gut microbiota and TMAO serum levels before endovascular revascularization and incidence of cardiovascular death during the follow-up period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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