NCT05111379|Unknown
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Sponsor study identifier
observational
40
1 country
1
Study Start
January 28, 2022
Actual (reported)Primary Completion
August 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2021
Actual (reported)November 8, 2021
Actual (reported)January 28, 2022
Actual (reported)August 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
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.
Blood sampling at two points in time: Baseline (Day 1) & 10-15 minutes after treadmill test (Day 2).
Patients with mild intermittent claudication.
Healthy controls.
Patients with mild intermittent claudication (Fontaine IIa).
Tartu University Hospital
Tartu, Tartu, 50406, Estonia
Whole blood, serum, plasma, frozen tissue.
Jaak Kals, MD, PhD
University of Tartu
Kaido Paapstel, MD, PhD
University of Tartu
Kalle Kilk, MD, PhD
University of Tartu
Holger Post, MD
University of Tartu
First Submitted
September 28, 2021
First Posted
November 8, 2021
Study Start
January 28, 2022
Actual (reported)Primary Completion
August 2023
Estimated (date passed)Change in local metabolomic profile after treadmill exercise as reflected by absolute concentrations of low-molecular metabolites in muscle biopsy.
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.
Data analysis after the enrollment period.
Correlations between baseline arterial functionality/hemodynamic parameters and exercise-induced changes in local metabolomic and inflammatory profiles.
Data analysis after the enrollment period.
Maximal walking distance on a treadmill (m).
During treadmill test (Day 2).
Ankle-brachial index (no units).
Baseline (Day 1).
Femoral artery intima-media thickness (mm).
Baseline (Day 1).
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 25, 2022
Record last verified: 2022-05
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