Tissue Lesions in Exercise Related Ischemia

Not Applicable

Completed

• Conditions: Peripheral Artery Disease; Ischemia
• Interventions: Other: Muscle Biopsy

• Registration Number: NCT02834351
• Lead Sponsor: University Hospital, Angers

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2016-06-16
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-15
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac group	Muscle Biopsy	Patients referred for saphenous withdrawal for coronary bypass Muscle biopsy during surgery
Peripheral artery diseased group	Muscle Biopsy	pad Patients referred for femoro popliteal bypass Muscle biopsy during surgery

Primary Outcome Measures

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

Trial Locations

Locations (1)

Uh Angers; 🇫🇷 Angers, France