Peripheral Arterial DiseaseNCT05757297
Gut Microbiota in Patients With Peripheral Arterial Disease and Chronic Limb-threatening Ischemia
An observational study of Peripheral Arterial Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: We will enroll consecutive subjects with PAD and CLTI requiring for endovascular revascularization and admitted to Internal Medicine Cardiovascular Unit of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- active cancer
- liver disease at functional status B or C according to Child-Pugh
- absolute contraindication to antiplatelet therapy
- thrombophilia
- contraindication to endovascular revascularization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Microbiota and Failure of Endovascular Revascularization in Diabetic Patients With Peripheral Arterial Disease and Chronic Limb-threatening Ischemia
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.
Read more
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.
- Conditions
- Peripheral Arterial Disease
- Keywords
- microbiota, gut microbiota, TMAO, MACE, MALE
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24-months follow-up
Secondary outcomes (3)
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.
Measured: 24-months follow-up
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.
Measured: 24-months follow-up
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.
Measured: 24-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flex Andrea, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757297
- Sponsor's protocol ID
- 5200
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota and Failure of Endovascular Revascularization in Diabetic Patients With Peripheral Arterial Disease and Chronic Limb-threatening Ischemia
- ClinicalTrials.gov ID
- NCT05757297
- Acronym / sponsor ID
- 5200
- Conditions
- Peripheral Arterial Disease
- Keywords
- microbiota, gut microbiota, TMAO, MACE, MALE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We will enroll consecutive subjects with PAD and CLTI requiring for endovascular revascularization and admitted to Internal Medicine Cardiovascular Unit of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between incidence of MALE and gut microbiota and TMAO serum levels
Time frame: 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.
3 secondary outcomes
Association between incidence of myocardial infarction and gut microbiota and TMAO serum levels
Time frame: 24-months follow-up
Association between incidence of stroke and gut microbiota and TMAO serum levels
Time frame: 24-months follow-up
Association between incidence of cardiovascular death and gut microbiota and TMAO serum levels
Time frame: 24-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Flex, MD, PhD (+39 3015 4293, andrea.flex@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between incidence of MALE and gut microbiota and TMAO serum levels (time frame: 24-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.