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

Italy130 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 24-months follow-up

Trial details

NCT IDNCT05757297

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-31

Contact for this trial

Andrea Flex, MD, PhD

+39 3015 4293 andrea.flex@policlinicogemelli.it

View on ClinicalTrials.gov More Peripheral Arterial Disease trials