Tissue Lesions in Exercise Related Ischemia

Peripheral Artery Disease Clinical Trial

— SARTORIUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834351
• Other study ID #: 2013-A00166-39
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: December 15, 2016
• Start date: July 2016
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Other:
• Muscle Biopsy
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.

Locations

Country	Name	City	State
France	Uh Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity differences in mitochondrial complex I between the distal and proximal levy in group 1 and group 2.	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.	1 week	No