Peripheral Arterial DiseaseMIVANCT05644158
Mitochondrial Function in Peripheral Arterial Disease
A study testing Revascularization and Exercise therapy in people with Peripheral Arterial Disease and Cardiovascular Diseases, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Cardiovascular Diseases
- What is being tested?
- Revascularization and Exercise therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2022to 31 Jan 2025
- Phase
- Interventional
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Isolated flow limiting arteriosclerotic lesion of the superficial femoral artery
- Unilateral grade II b (Fontaine) peripheral arterial disease
- Informed consent
Who cannot join
- Flow limiting arteriosclerotic lesions of the infrarenal aorta, iliac arteries or common/ deep femoral artery
- Contraindication for exercise therapy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck, Tyrol, 6020
Alexandra Gratl, MD, 004350504 80804, alexandra.gratl@i-med.ac.at
About this study
Official title: Effect of Different Treatment Strategies on Mitochondrial Function in Peripheral Arterial Disease - a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Revascularization, Exercise therapy
- Keywords
- mitochondrial function, respirometry, near infrared spectroscopy, endothelial dysfunction, peripheral arterial disease, exercise training, revascularisation
- Medical subject headings
- Peripheral Arterial Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevascularizationProcedure or surgery
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) .
Exercise therapyOther
Home-based monitored exercise training (walking), 3 times a week, monitored with log book and activity sensors.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Active comparator | Patients with intermittent claudication will receive conservative treatment with monitored exercise training for a total of 12 weeks (home-based training, minimum of three times a week, documented by using a diary with documentation of the type, the intensity and the duration of the training as well as by using a physical activity monitoring system (Move 4, Karlsruhe, Germany). Receives: Other: Exercise therapy |
| Revascularization group | Active comparator | will receive revascularization of the underlying atherosclerosis lesion of the superficial femoral artery. 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 and patients with long superficial femoral artery lesions (>25 cm) will be subdivided into group 2B with open surgical treatment Receives: Procedure: Revascularization |
| Healthy control group | No intervention | Patients undergoing surgery for symptomatic varicose veins with excluded PAD will serve as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mitochondrial function after defined treatment
High-resolution respirometry of muscle biopsy sample
Measured: After 12 weeks - compared to baseline at inclusion
Change of near infrared spectroscopy
Near infrared spectroscopy measurement of calf
Measured: After 12 weeks - compared to baseline at inclusion
Secondary outcomes (3)
Change in flow mediated dilation of the brachial artery
Evaluation of endothelial dysfunction with ultrasound measurements of flow mediated dilation of the brachial artery.
Measured: After 12 weeks - compared to baseline at inclusion
Change in standardized 6-minutes walking test
Evaluation of cardiovascular risk with measurement of maximal walking distance (meters) in 6 minutes.
Measured: After 12 weeks - compared to baseline at inclusion
Change in ankle-brachial index
Evaluation of hemodynamic parameters (ankle-brachial index).
Measured: After 12 weeks - compared to baseline at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled trial 1. Exercise group 2. Revascularization group 3. Healthy control group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Wipper, MD, Study chair, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644158
- Sponsor's protocol ID
- 1194/2019
- Acronym
- MIVA
- Status last verified
- Mar 2024
- First submitted
- 7 Nov 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schoenherr L, Heidler J, Kluckner M, Lobenwein D, Pesta D, Frese JP, Wipper SH, Gratl A. A Randomized Control Trial Investigating the Effect of Different Treatment Strategies on Mitochondrial Function in Peripheral Arterial Disease: A Study Protocol. J Surg Res. 2025 Mar;307:78-85. doi: 10.1016/j.jss.2025.01.014. Epub 2025 Feb 22.
PubMed 39987612
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Treatment Strategies on Mitochondrial Function in Peripheral Arterial Disease - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05644158
- Acronym / sponsor ID
- MIVA / 1194/2019
- Keywords
- mitochondrial function, respirometry, near infrared spectroscopy, endothelial dysfunction, peripheral arterial disease, exercise training, revascularisation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 9 Dec 2022 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective randomized controlled trial 1. Exercise group 2. Revascularization group 3. Healthy control group
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Active comparator | Other: Exercise therapyPatients with intermittent claudication will receive conservative treatment with monitored exercise training for a total of 12 weeks (home-based training, minimum of three times a week, documented by using a diary with documentation of the type, the intensity and the duration of the training as well as by using a physical activity monitoring system (Move 4, Karlsruhe, Germany). |
| Revascularization group | Active comparator | Procedure: Revascularizationwill receive revascularization of the underlying atherosclerosis lesion of the superficial femoral artery. 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 and patients with long superficial femoral artery lesions (>25 cm) will be subdivided into group 2B with open surgical treatment |
| Healthy control group | No intervention | –Patients undergoing surgery for symptomatic varicose veins with excluded PAD will serve as a control group. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Isolated flow limiting arteriosclerotic lesion of the superficial femoral artery
- Unilateral grade II b (Fontaine) peripheral arterial disease
- Informed consent
Key exclusion criteria (2 listed)
- Flow limiting arteriosclerotic lesions of the infrarenal aorta, iliac arteries or common/ deep femoral artery
- Contraindication for exercise therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RevascularizationDepending 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) . | Procedure or surgery | Revascularization group |
| Exercise therapyHome-based monitored exercise training (walking), 3 times a week, monitored with log book and activity sensors. | Other | Exercise group |
Primary outcome
Change in mitochondrial function after defined treatment
Time frame: After 12 weeks - compared to baseline at inclusion
High-resolution respirometry of muscle biopsy sample
Change of near infrared spectroscopy
Time frame: After 12 weeks - compared to baseline at inclusion
Near infrared spectroscopy measurement of calf
3 secondary outcomes
Change in flow mediated dilation of the brachial artery
Time frame: After 12 weeks - compared to baseline at inclusion
Change in standardized 6-minutes walking test
Time frame: After 12 weeks - compared to baseline at inclusion
Change in ankle-brachial index
Time frame: After 12 weeks - compared to baseline at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 39987612Schoenherr L, Heidler J, Kluckner M, Lobenwein D, Pesta D, Frese JP, Wipper SH, Gratl A. A Randomized Control Trial Investigating the Effect of Different Treatment Strategies on Mitochondrial Function in Peripheral Arterial Disease: A Study Protocol. J Surg Res. 2025 Mar;307:78-85. doi: 10.1016/j.jss.2025.01.014. Epub 2025 Feb 22.
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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.
Sabine Wipper, MD study chair
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revascularization and Exercise therapy in people with Peripheral Arterial Disease and Cardiovascular Diseases, run by Medical University Innsbruck at 1 site in Austria.
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 3 inclusion and 2 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 13 Mar 2024. 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 Austria. 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 Alexandra Gratl, MD (00435050480804, alexandra.gratl@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mitochondrial function after defined treatment (time frame: After 12 weeks - compared to baseline at inclusion). 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?
On the ClinicalTrials.gov record for NCT05644158, which also lists 1 linked publication.
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 13 Mar 2024.