Peripheral Arterial DiseaseNCT05757271
Serum Levels of Klotho as a Possible Biomarker of Peripheral Artery Disease
An observational study of Peripheral Arterial Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Klotho, a membrane-bound protein co-receptor for fibroblast growth factor 23 (FGF23), is involved in atherosclerotic process and cardiovascular diseases. It regulates blood glucose and cholesterol levels. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 207 participants
- Where
- 1 siteItaly
- Study dates
- 23 Oct 2019to 31 Oct 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- 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 40 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
- pregnancy
- acute infections at present or 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
- diabetic peripheral neuropathy
Show all 14Show fewer
- homozygous familial hypercholesterolemia
- absolute contraindication to antiplatelet therapy
- thrombophilia
- active cancer
- active autoimmune disease
- liver disease at functional status B or C according to Child-Pugh
- contraindication to endovascular revascularization
- organ transplantation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome
Andrea Flex, MD, PhD, + 39 06 3015 4293, andrea.flex@policlinicogemelli.it
About this study
Official title: Serum Levels of Klotho as a Possible Biomarker of Peripheral Artery Disease Progression
Klotho, a membrane-bound protein co-receptor for fibroblast growth factor 23 (FGF23), is involved in atherosclerotic process and cardiovascular diseases. It regulates blood glucose and cholesterol levels. In addition, the lack of klotho has been associated with endothelial dysfunction, calcification and accumulation of cholesterol in the arteries, leading to coronary heart disease.
The goal of this observational study is to evaluate the potential use of circulating klotho and FGF23 serum levels as biomarkers of major adverse limb events (MALE) and major adverse cardiovascular events (MACE) in patients with peripheral artery disease (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 klotho and FGF23 serum levels and major adverse limb events (MALE) after lower extremity revascularization.
- association between klotho and FGF23 serum levels and major adverse cardiovascular events (MACE) after lower extremity revascularization.
Patients with PAD and CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating klotho and FGF23 before the endovascular procedure.
Incidence of MACE and MALE will be collected in a 12-months follow-up and will be associated with klotho and FGF23 serum levels at baseline.
- Conditions
- Peripheral Arterial Disease
- Keywords
- Klotho, FGF23, MALE, MACE
- 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 klotho and FGF23 serum levels
To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and MALE during the follow-up period.
Measured: 12-months follow-up
Secondary outcomes (3)
Association between incidence of myocardial infarction and klotho and FGF23 serum levels
To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and myocardial infarction during the follow-up period.
Measured: 12-months follow-up
Association between incidence of stroke and klotho and FGF23 serum levels
To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and stroke during the follow-up period.
Measured: 12-months follow-up
Association between incidence of cardiovascular death and klotho and FGF23 serum levels
To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and cardiovascular death during the follow-up period.
Measured: 12-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 start23 Oct 2019
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (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.
- 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
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flex Andrea, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Flex Andrea, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757271
- Sponsor's protocol ID
- 2753
- 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
- Serum Levels of Klotho as a Possible Biomarker of Peripheral Artery Disease Progression
- ClinicalTrials.gov ID
- NCT05757271
- Acronym / sponsor ID
- 2753
- Conditions
- Peripheral Arterial Disease
- Keywords
- Klotho, FGF23, MALE, MACE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (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.
Klotho, a membrane-bound protein co-receptor for fibroblast growth factor 23 (FGF23), is involved in atherosclerotic process and cardiovascular diseases. It regulates blood glucose and cholesterol levels. In addition, the lack of klotho has been associated with endothelial dysfunction, calcification and accumulation of cholesterol in the arteries, leading to coronary heart disease.
The goal of this observational study is to evaluate the potential use of circulating klotho and FGF23 serum levels as biomarkers of major adverse limb events (MALE) and major adverse cardiovascular events (MACE) in patients with peripheral artery disease (PAD) and chronic limb threatening ischemia (CLTI) requiring a procedure of endovascular revascularization.
The main questions it aims to answer are:
- association between klotho and FGF23 serum levels and major adverse limb events (MALE) after lower extremity revascularization.
- association between klotho and FGF23 serum levels and major adverse cardiovascular events (MACE) after lower extremity revascularization.
Patients with PAD and CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating klotho and FGF23 before the endovascular procedure.
Incidence of MACE and MALE will be collected in a 12-months follow-up and will be associated with klotho and FGF23 serum levels at baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- 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 40 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 (14 listed)
- pregnancy
- acute infections at present or 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 klotho and FGF23 serum levels
Time frame: 12-months follow-up
To evaluate the association between klotho and FGF23 serum levels before endovascular revascularization and MALE during the follow-up period.
3 secondary outcomes
Association between incidence of myocardial infarction and klotho and FGF23 serum levels
Time frame: 12-months follow-up
Association between incidence of stroke and klotho and FGF23 serum levels
Time frame: 12-months follow-up
Association between incidence of cardiovascular death and klotho and FGF23 serum levels
Time frame: 12-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.
Flex Andrea, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 14 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 Flex Andrea, MD, PhD (+39 06 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 klotho and FGF23 serum levels (time frame: 12-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.