Peripheral Arterial Occlusive Disease Fontaine Stage IIaNCT05111379
Acute Local Metabolomic Alterations in Blood and Muscle Tissue in Intermittent Claudication
An observational study of Peripheral Arterial Occlusive Disease Fontaine Stage IIa, run by University of Tartu at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Occlusive Disease Fontaine Stage IIa
- How many people
- 40 participants
- Where
- 1 siteEstonia
- Study dates
- 28 Jan 2022to Aug 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with mild intermittent claudication (Fontaine IIa).
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- active rheumatism;
- other diseases and factors that markedly hinder the subject's ability to walk during the treadmill exercise.
- For control group exclusively: history of lower extremity arterial disease / ABI <1.0 or >1.4.
Trial locations and contacts
1 site in 1 country.
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu, Tartu, 50406
Jaak Kals, MD, PhD, +372 731 8292, jaak.kals@kliinikum.ee
About this study
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.
- Keywords
- lower extremity arterial disease, peripheral artery disease, intermittent claudication, local, metabolism, metabolomics, arteriovenous gradients, biomarkers, inflammation, ischemia-reperfusion injury
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Inflammation, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LEAD (Fontaine IIa) | Patients with mild intermittent claudication. | |
| Control | Healthy controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in local metabolomic profile after treadmill exercise as reflected by arteriovenous gradients of low-molecular metabolites.
Measured using liquid chromatography combined with mass spectrometry (AbsoluteIDQ MxP Quant 500 Kit, BIOCRATES Life Sciences AG, Austria).
Measured: 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).
Measured using enzyme linked immunosorbent assay. Measurement unit: ng/mL.
Measured: Blood sampling at two points in time: Baseline (Day 1) & 10-15 minutes after treadmill test (Day 2).
Secondary outcomes (3)
Change in local metabolomic profile after treadmill exercise as reflected by absolute concentrations of low-molecular metabolites in muscle biopsy.
Measured using liquid chromatography combined with mass spectrometry (AbsoluteIDQ MxP Quant 500 Kit, BIOCRATES Life Sciences AG, Austria).
Measured: Biopsy at two points in time: Baseline (Day 1) & 15-20 minutes after treadmill test (Day 2).
Correlations between maximal walking distance and exercise-induced changes in local metabolomic and inflammatory profiles.
Measured: Data analysis after the enrollment period.
Correlations between baseline arterial functionality/hemodynamic parameters and exercise-induced changes in local metabolomic and inflammatory profiles.
Measured: Data analysis after the enrollment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start28 Jan 2022
- Primary completionAug 2023 (estimated)
- Study completionAug 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 Occlusive Disease Fontaine Stage IIaStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- Tartu University Hospital, Estonian Science Foundation
- Responsible party
- Principal investigator, Jaak Kals, MD, University of Tartu
- Investigators
- Jaak Kals, MD, PhD, Principal investigator, University of TartuKaido Paapstel, MD, PhD, Study chair, University of TartuKalle Kilk, MD, PhD, Study chair, University of TartuHolger Post, MD, Study chair, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111379
- Sponsor's protocol ID
- 350/T-2
- Status last verified
- May 2022
- First submitted
- 28 Sep 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Local Metabolomic Alterations in Blood and Muscle Tissue in Intermittent Claudication
- ClinicalTrials.gov ID
- NCT05111379
- Acronym / sponsor ID
- 350/T-2
- Keywords
- lower extremity arterial disease, peripheral artery disease, intermittent claudication, local, metabolism, metabolomics, arteriovenous gradients, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- Tartu University Hospital, Estonian Science Foundation
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 8 Nov 2021 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEAD (Fontaine IIa) | – | –Patients with mild intermittent claudication. |
| Control | – | –Healthy controls. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mild intermittent claudication (Fontaine IIa).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (33 listed)
- 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;
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
Change in local metabolomic profile after treadmill exercise as reflected by arteriovenous gradients of low-molecular metabolites.
Time frame: Blood sampling at two points in time: Baseline (Day 1) & 10-15 minutes after treadmill test (Day 2).
Measured using liquid chromatography combined with mass spectrometry (AbsoluteIDQ MxP Quant 500 Kit, BIOCRATES Life Sciences AG, Austria).
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).
Time frame: Blood sampling at two points in time: Baseline (Day 1) & 10-15 minutes after treadmill test (Day 2).
Measured using enzyme linked immunosorbent assay. Measurement unit: ng/mL.
3 secondary outcomes
Change in local metabolomic profile after treadmill exercise as reflected by absolute concentrations of low-molecular metabolites in muscle biopsy.
Time frame: Biopsy at two points in time: Baseline (Day 1) & 15-20 minutes after treadmill test (Day 2).
Correlations between maximal walking distance and exercise-induced changes in local metabolomic and inflammatory profiles.
Time frame: Data analysis after the enrollment period.
Correlations between baseline arterial functionality/hemodynamic parameters and exercise-induced changes in local metabolomic and inflammatory profiles.
Time frame: Data analysis after the enrollment period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Endothelial Research CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Jaak Kals, MD, PhD principal investigator
University of Tartu
Kaido Paapstel, MD, PhD study chair
University of Tartu
Kalle Kilk, MD, PhD study chair
University of Tartu
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 Occlusive Disease Fontaine Stage IIa, run by University of Tartu at 1 site in Estonia.
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 2 inclusion and 33 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 25 May 2022. 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 Estonia. 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 Jaak Kals, MD, PhD (+372 731 8292, jaak.kals@kliinikum.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in local metabolomic profile after treadmill exercise as reflected by arteriovenous gradients of low-molecular metabolites. (time frame: Blood sampling at two points in time: Baseline (Day 1) & 10-15 minutes after treadmill test (Day 2).). The study lists 2 primary outcomes in all. 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 25 May 2022.