UnknownNot Applicable

Acute Local Metabolomic Alterations in Blood and Muscle Tissue in Intermittent Claudication

Estonia40 participantsStarted 2022-01-28

Plain-language summary

The most common clinical presentation of lower extremity arterial disease is intermittent claudication. Current understanding of the pathophysiology of intermittent claudication, as well as its treatment options are limited. The progression of the disease may lead to lower limb amputation, which is devastating for patients' quality of life and is a huge socio-economic burden to society. Current study allows to determine the acute local metabolomic alterations in the ischaemic limb of the patient with intermittent claudication, and investigate the associations between the metabolomic alterations and the patient's maximal walking distance. This provides potentially valuable insight into the pathophysiology of this disease, and helps lay the groundwork for identifying potential novel targets for instituting more effective therapies for this high-risk population.

Who can participate

Age range

18 Years – 80 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: * LEAD group: Patients with diagnosis of lower extremity arterial disease (Fontaine IIa). * Control group: Healthy volunteers with no leg symptoms and an ankle-brachial index (ABI) of 1.0-1.4. Exclusion Criteria: * Fontaine stages I or IIb-IV * Exacerbation of limb ischaemia within the preceding 2 weeks; * strong rest pain of any cause; * age \<18 or \>80 years; * fasting \< 6 hours; * time since last use of tobacco products \< 6 hours; * body mass index ≥ 35 kg/m2 * poor sonographic visibility of femoral artery; * angina; * cardiac arrhythmia at the time of presentation; * presence of cardiac pacemaker; * myocardial infarction within the preceding 3 months; * stroke within the preceding 6 months; * ongoing anticoagulant therapy; * ongoing dual antiplatelet therapy; * any revascularization within the preceding 3 month; * marked heart failure (NYHA III-IV); * blood pressure ≥ 180/110 mmHg; * blood pressure \<100/70 mmHg; * clinically significant heart valve disease; * acute infectious disease; * active malignancy or chemotherapy or disease-free \< 5 years; * type I diabetes or insulin therapy; * other clinically significant and untreated endocrine disorders; * moderate to severe bronchial asthma (GINA 2016); * severe chronic obstructive pulmonary disease (mMRC grade 3-4); * acute (KDIGO 2012) or chronic renal disease (eGFR-EPI \<30mL/min/1.73 m2); * acute or chronic liver disease; * anemia (\<110 g/L); * neuroinflammatory or neurodegenerative disease; * …

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

Change in local metabolomic profile after treadmill exercise as reflected by arteriovenous gradients of low-molecular metabolites.

Timeframe: Blood sampling at two points in time: Baseline (Day 1) & 10-15 minutes after treadmill test (Day 2).

Change in local inflammatory profile after treadmill exercise as reflected by arteriovenous gradients of inflammatory mediators (IL-6, MPO, SOD, NOX isoform 1, NOX isoform 2, NOX isoform 5, nitrotyrosine, 8-iso-PGF2α).

Timeframe: Blood sampling at two points in time: Baseline (Day 1) & 10-15 minutes after treadmill test (Day 2).

Trial details

NCT IDNCT05111379

SponsorUniversity of Tartu

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08

Contact for this trial

Jaak Kals, MD, PhD

+372 731 8292 jaak.kals@kliinikum.ee

View on ClinicalTrials.gov More Peripheral Arterial Occlusive Disease Fontaine Stage IIa trials

Plain-language summary

Who can participate

Age range

18 Years – 80 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.

What they're measuring

Change in local metabolomic profile after treadmill exercise as reflected by arteriovenous gradients of low-molecular metabolites.

Timeframe: Blood sampling at two points in time: Baseline (Day 1) & 10-15 minutes after treadmill test (Day 2).