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Completed

NCT Number: NCT02834351

Tissue Lesions in Exercise Related Ischemia

The purpose of this study is to evaluate the effect of muscle ischemia during claudication on mitochondrial function.

Comparison to patients with arterial disease but absence of lower limb claudication (Cardiac group) feasibility study.

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Key information

Conditions

Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uh Angers

Angers, 49933, France

About this study

Assess the feasibility of the study of micro-vascular function and mitochondrial on muscle sample (sartorius) in a group of arterial disease and non arteriopathy group.

Analysis of the activity of mitochondrial chain Immunochemistry of tissue markers

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intervention for femoropopliteal bypass (PAD group)
  • Intervention for saphenous withdrawal for coronary bypass surgery (cardiac group)

Exclusion criteria

  • Participate in another biomedical research
  • Pregnant woman

Treatment and study plan

Muscle Biopsy

Other

A distal and proximal biopsy of the sartorius muscles ( 0.5 cm3 each) will be performed during surgery for saphenous vein withdrawal (cardiac group) or arterial bypass (PAD group) The samples are then treated with neurovascular and mitochondrial biology laboratory.

the activity of the complex 1 is analyzed and compared between the 2 groups.

Primary outcomes

  1. Activity differences in mitochondrial complex I between the distal and proximal levy in group 1 and group 2.

    Time frame: 1 week

    Measurement of mitochondrial complex 1 activity (arbitrary units) on muscle biopsies by the laboratory of biochemistry. Comparison of the results observed on the same miuscle at the proximal level (assumed normal in both groups) and distal level (assumed ischemic in claudicants but not in cardiac patients without limb symptoms.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Atteinte Tissulaire au Cours de l'ischémie Chronique d'Effort. Validation d'un modèle d'étude du Muscle Sartorius Humain

Acronym: SARTORIUS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2016
Registry last updated
Dec 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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