Mitochondrial Function in Peripheral Arterial Disease

NCT05644158 | Recruiting

• 1 other identifier: 1194/2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Cardiovascular Diseases

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in mitochondrial function after defined treatment

  High-resolution respirometry of muscle biopsy sample

  After 12 weeks - compared to baseline at inclusion

• Change of near infrared spectroscopy

  Near infrared spectroscopy measurement of calf

  After 12 weeks - compared to baseline at inclusion

Secondary Outcomes (3)

• Change in flow mediated dilation of the brachial artery

  After 12 weeks - compared to baseline at inclusion

• Change in standardized 6-minutes walking test

  After 12 weeks - compared to baseline at inclusion

• Change in ankle-brachial index

  After 12 weeks - compared to baseline at inclusion

Study Arms (3)

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).

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

Procedure: Revascularization

Healthy control group

NO INTERVENTION

Patients undergoing surgery for symptomatic varicose veins with excluded PAD will serve as a control group.

Interventions

Revascularization PROCEDURE

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) .

Revascularization group

Exercise therapy OTHER

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

Exercise group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Related Publications (1)

• 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.

  PMID: 39987612 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Cardiovascular Diseases

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Sabine Wipper, MD

  Medical University of Innsbruck

  STUDY CHAIR

Central Study Contacts

Alexandra Gratl, MD

CONTACT

00435050480804; alexandra.gratl@i-med.ac.at

Michaela Kluckner, MD

CONTACT

00435050422587; michaela.kluckner@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: December 9, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

AU (1)