NCT02834351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

4 months

First QC Date

June 16, 2016

Last Update Submit

December 15, 2016

Conditions

IschemiaPeripheral Artery Disease

Outcome Measures

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.

    1 week

Study Arms (2)

Peripheral artery diseased group

ACTIVE COMPARATOR

pad Patients referred for femoro popliteal bypass Muscle biopsy during surgery

Other: Muscle Biopsy

Cardiac group

SHAM COMPARATOR

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

Other: Muscle Biopsy

Interventions

Muscle BiopsyOTHER

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.

Cardiac groupPeripheral artery diseased group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Participate in another biomedical research
  • Pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

IschemiaPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Pierre ABRAHAM, PROFESSOR

    UH ANGERS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

July 15, 2016

Study Start

July 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 19, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)