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Tissue Lesions in Exercise Related Ischemia (SARTORIUS)

Primary Purpose

Ischemia, Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Muscle Biopsy
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uh Angers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Peripheral artery diseased group

Cardiac group

Arm Description

pad Patients referred for femoro popliteal bypass Muscle biopsy during surgery

Patients referred for saphenous withdrawal for coronary bypass Muscle biopsy during surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2016
Last Updated
December 15, 2016
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02834351
Brief Title
Tissue Lesions in Exercise Related Ischemia
Acronym
SARTORIUS
Official Title
Atteinte Tissulaire au Cours de l'ischémie Chronique d'Effort. Validation d'un modèle d'étude du Muscle Sartorius Humain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Peripheral Artery Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peripheral artery diseased group
Arm Type
Active Comparator
Arm Description
pad Patients referred for femoro popliteal bypass Muscle biopsy during surgery
Arm Title
Cardiac group
Arm Type
Sham Comparator
Arm Description
Patients referred for saphenous withdrawal for coronary bypass Muscle biopsy during surgery
Intervention Type
Other
Intervention Name(s)
Muscle Biopsy
Intervention Description
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 Outcome Measure Information:
Title
Activity differences in mitochondrial complex I between the distal and proximal levy in group 1 and group 2.
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre ABRAHAM, PROFESSOR
Organizational Affiliation
UH ANGERS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uh Angers
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Tissue Lesions in Exercise Related Ischemia

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