NCT04209413

Brief Summary

mPTP (Mitochondrial Permeability Transition Pore) is a channel formed by a protein complex integrated into the inner membrane of mitochondria. Its opening is related to the elevation of the intra-mitochondrial calcium concentration and will result in: a mitochondrial decoupling, a rupture of the metabolic gradient and the release of pro-apoptotic factors. The objective of this study is the development of a new ex vivo technique for characterizing mPTP by a dual measurement combining oxygraphy and fluorimetry on permeabilized skeletal muscle fibers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

December 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

December 20, 2019

Last Update Submit

January 21, 2020

Conditions

Anterior Cruciate Ligament Injuries

Keywords

Anterior Cruciate Ligament operationSkeletal muscleMitochondriaCalciumMitochondrial permeability transition pore opening (mPTP opening)

Outcome Measures

Primary Outcomes (1)

  • Determination of the mPTP calcium sensitivity mPTP

    The goal is to study the feasibility of a new method for the analysis of the calcium sensitivity of mPTP on non-phantomized permeabilized muscle fibers by coupled use of oxygen and fluorimetry techniques. Calcium quantity and time required to open mPTPs in permeabilized muscle fibers will be measured, in the presence or absence of ciclosporin A, observable by total inhibition of mitochondrial respiration (synonymous with release of NADH).

    day 0

Secondary Outcomes (1)

  • Identification of mPTP opening discrimination factors

    Day 0

Interventions

Patients referred for a knee ligamentoplastyPROCEDURE

knee ligamentoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for a knee ligamentoplasty

You may qualify if:

  • Patients aged over 18 ;
  • Patients referred for a knee ligamentoplasty (DIDT technique) ;
  • Patients who signed the non-opposition form after being informed ;
  • Patients benefiting from or affiliated to a social security.

You may not qualify if:

  • \- Patients under guardianship, curatorship or deprived of liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Ruddy Richard

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2019

First Posted

December 24, 2019

Study Start

January 20, 2020

Primary Completion

November 1, 2020

Study Completion

February 1, 2021

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

FR(1)