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Mitochondrial Function in Peripheral Arterial Disease

Effect of Different Treatment Strategies on Mitochondrial Function in Peripheral Arterial Disease - a Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05644158
Acronym
MIVA
Enrollment
80
Registered
2022-12-09
Start date
2022-11-01
Completion date
2025-01-31
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Peripheral Arterial Disease

Keywords

mitochondrial function, respirometry, near infrared spectroscopy, endothelial dysfunction, peripheral arterial disease, exercise training, revascularisation

Brief summary

The aim of this study is to investigate the effect of different treatment strategies on mitochondrial function and to correlate in-vitro results to findings from in-vivo measurements of mitochondrial function. The authors hypothesize that interventional revascularization and therefore the restoration of blood and oxygen supply is more relevant to mitochondrial function compared to the effect of exercise training.

Detailed description

Resulting from a chronic narrowing of arteries by atherosclerotic lesions, the leading clinical symptom of peripheral arterial disease (PAD), a walking induced pain, reduces quality of life of patients. Affected muscle regions are altered by a characterized myopathy and mitochondria are known to play a crucial role in this pathophysiological mechanism. There are different methodological approaches to investigate mitochondrial function in-vivo as well as in-vitro. Regarding our own preliminary data, mitochondria are known to recover after successful revascularization. The effect of different treatment strategies on mitochondrial function and the correlation of in-vitro to clinical more applicable in-vivo methods was understudied so far. The overall aim of this study is to investigate the effect of different treatment strategies on mitochondrial function and to correlate in-vitro results to findings from in-vivo measurements of mitochondrial function. The authors hypothesize that interventional revascularization and therefore the restoration of blood and oxygen supply is more relevant to mitochondrial function compared to the effect of exercise training. Patients with isolated pathologies of the superficial femoral artery and symptomatic PAD (Fontaine stage IIB) will be included and randomized to different treatment groups (conservative treatment versus interventional revascularization). Near-infrared refracted spectroscopy and the TIVITA ® hyperspectral camera will be used for in-vivo measurement of peripheral oxygen saturation and distal perfusion before and after an exercise. Muscle biopsies will be obtained from affected (gastrocnemius muscle) as well as from unaffected muscle (lateral vastus muscle) shortly before and 12 weeks after initiating treatment. Muscle samples will be investigated by measurement of CSA regarding mitochondrial content and HRR regarding mitochondrial respiration as well as for oxidative stress.

Interventions

PROCEDURERevascularization

Depending on the exact morphology of the lesion, patients with short superficial femoral artery lesions (\<25 cm) will be subdivided into group 2A with endovascular treatment (percutaneous transluminal angioplasty with or without stenting) and patients with long superficial femoral artery lesions (\>25 cm) will be subdivided into group 2B with open surgical treatment (femoropopliteal bypass) .

OTHERExercise therapy

Home-based monitored exercise training (walking), 3 times a week, monitored with log book and activity sensors.

Sponsors

Medical University Innsbruck
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Prospective randomized controlled trial 1. Exercise group 2. Revascularization group 3. Healthy control group

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* Isolated flow limiting arteriosclerotic lesion of the superficial femoral artery * Unilateral grade II b (Fontaine) peripheral arterial disease * Informed consent

Exclusion criteria

* Flow limiting arteriosclerotic lesions of the infrarenal aorta, iliac arteries or common/ deep femoral artery * Contraindication for exercise therapy

Design outcomes

Primary

MeasureTime frameDescription
Change in mitochondrial function after defined treatmentAfter 12 weeks - compared to baseline at inclusionHigh-resolution respirometry of muscle biopsy sample
Change of near infrared spectroscopyAfter 12 weeks - compared to baseline at inclusionNear infrared spectroscopy measurement of calf

Secondary

MeasureTime frameDescription
Change in flow mediated dilation of the brachial arteryAfter 12 weeks - compared to baseline at inclusionEvaluation of endothelial dysfunction with ultrasound measurements of flow mediated dilation of the brachial artery.
Change in standardized 6-minutes walking testAfter 12 weeks - compared to baseline at inclusionEvaluation of cardiovascular risk with measurement of maximal walking distance (meters) in 6 minutes.
Change in ankle-brachial indexAfter 12 weeks - compared to baseline at inclusionEvaluation of hemodynamic parameters (ankle-brachial index).

Countries

Austria

Contacts

Primary ContactAlexandra Gratl, MD
alexandra.gratl@i-med.ac.at00435050480804
Backup ContactMichaela Kluckner, MD
michaela.kluckner@i-med.ac.at00435050422587

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026