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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05757297
• Other study ID #: 5200
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Andrea Flex, MD, PhD
• Phone: +39 3015 4293
• Email: andrea.flex[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between incidence of MALE and gut microbiota and TMAO serum levels	To evaluate the association between gut microbiota and TMAO serum levels before endovascular revascularization and incidence of MALE during the follow-up period.	24-months follow-up
Secondary	Association between incidence of myocardial infarction and gut microbiota and TMAO serum levels	To evaluate the association between gut microbiota and TMAO serum levels before endovascular revascularization and incidence of myocardial infarction during the follow-up period.	24-months follow-up
Secondary	Association between incidence of stroke and gut microbiota and TMAO serum levels	To evaluate the association between gut microbiota and TMAO serum levels before endovascular revascularization and incidence of stroke during the follow-up period.	24-months follow-up
Secondary	Association between incidence of cardiovascular death and gut microbiota and TMAO serum levels	To evaluate the association between gut microbiota and TMAO serum levels before endovascular revascularization and incidence of cardiovascular death during the follow-up period.	24-months follow-up