CClinicalTrials.gg
CompletedNCT02834351SARTORIUSUpdated Dec 19, 2016

Tissue Lesions in Exercise Related Ischemia

An interventional study of Muscle Biopsy in Ischemia and Peripheral Artery Disease, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-19.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Ischemia
  • Peripheral Artery Disease
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 36 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Participate in another biomedical research
  • Pregnant woman
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    Peripheral artery diseased group

    pad Patients referred for femoro popliteal bypass Muscle biopsy during surgery

    Other: Muscle Biopsy

  • Sham comparator
    Cardiac group

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

    Other: Muscle Biopsy

Interventions

  • OtherMuscle 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week

07

Study locations

1 site
  • Uh Angers
    Angers, 49933, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02834351
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Jul 15, 2016
Start date
Jul 2016
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Dec 19, 2016

Study contacts

Pierre ABRAHAM, PROFESSOR
principal investigator · UH ANGERS

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion