Anterior Cruciate Ligament InjuriesCOMMEFNCT04209413
Control of the Opening of mPTP by Ex Vivo Measurements on Permeabilized Muscle Fibers (COMMEF)
An observational study of Anterior Cruciate Ligament Injuries, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Patients referred for a knee ligamentoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2020to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for a knee ligamentoplasty
Who may be able to join
- 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.
Who cannot join
- Patients under guardianship, curatorship or deprived of liberty.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Ruddy Richard, rrichard@chu-clermontferrand.fr
Ruddy Richard
About this study
Official title: Control of the Opening of mPTP by Ex Vivo Measurements on Permeabilized Muscle Fibers
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.
Read the detailed description
The development of new expertise in the study of mPTP is part of an approach to optimize the processing of muscle samples. The aim of this work is to evaluate the feasibility and reproducibility of a method of analysis on muscle fibers only permeabilized, while coupling two complementary techniques, oxygraphy and fluorimetry. Its principle is based on the knowledge that the opening of the mPTP leads to an inhibition of respiration at the level of the complex I of the respiratory chain. This inhibition is the consequence of the escape from mitochondria of the reduced form of nicotinamide adenine dinucleotide (NADH, i.e. substrate of complex I) concomitant with the opening of mPTP. Thus, the oxygraphy must allow the observation of the inhibition of respiration synonymous with the non-availability of the substrate of the complex I and thus indirectly reflect the opening of the mPTP. For its part, the fluorimetry must allow, in the presence of a fluorescent calcium indicator (i.e. Calcium Green), the observation of the release of calcium synonymous with the opening of the mPTP.
Once validated, this technique should make it possible to evaluate in situ the sensitivity of mPTP to calcium. In a context of application within clinical protocols, the evaluation of the mPTP calcium sensitivity should contribute to a better understanding of the physiological and physio-pathological mechanisms of adaptation of muscle tissue.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Patients referred for a knee ligamentoplasty
- Keywords
- Anterior Cruciate Ligament operation, Skeletal muscle, Mitochondria, Calcium, Mitochondrial permeability transition pore opening (mPTP opening)
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients referred for a knee ligamentoplastyProcedure or surgery
knee ligamentoplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 0
Secondary outcomes (1)
Identification of mPTP opening discrimination factors
Evaluate the possibility of population discrimination by this new method of analysis (i.e. variability by age and duration of functional impotence before intervention of the amount of calcium required to open the mPTP).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start20 Jan 2020
- Primary completionNov 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Responsible party
- Sponsor
- Investigators
- Ruddy Richard, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209413
- Sponsor's protocol ID
- RNI 2019 RICHARD
- Other IDs
- 2019-A01109-48
- Acronym
- COMMEF
- Status last verified
- Jan 2020
- First submitted
- 20 Dec 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of the Opening of mPTP by Ex Vivo Measurements on Permeabilized Muscle Fibers
- ClinicalTrials.gov ID
- NCT04209413
- Acronym / sponsor ID
- COMMEF / RNI 2019 RICHARD
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- Anterior Cruciate Ligament operation, Skeletal muscle, Mitochondria, Calcium, Mitochondrial permeability transition pore opening (mPTP opening)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The development of new expertise in the study of mPTP is part of an approach to optimize the processing of muscle samples. The aim of this work is to evaluate the feasibility and reproducibility of a method of analysis on muscle fibers only permeabilized, while coupling two complementary techniques, oxygraphy and fluorimetry. Its principle is based on the knowledge that the opening of the mPTP leads to an inhibition of respiration at the level of the complex I of the respiratory chain. This inhibition is the consequence of the escape from mitochondria of the reduced form of nicotinamide adenine dinucleotide (NADH, i.e. substrate of complex I) concomitant with the opening of mPTP. Thus, the oxygraphy must allow the observation of the inhibition of respiration synonymous with the non-availability of the substrate of the complex I and thus indirectly reflect the opening of the mPTP. For its part, the fluorimetry must allow, in the presence of a fluorescent calcium indicator (i.e. Calcium Green), the observation of the release of calcium synonymous with the opening of the mPTP.
Once validated, this technique should make it possible to evaluate in situ the sensitivity of mPTP to calcium. In a context of application within clinical protocols, the evaluation of the mPTP calcium sensitivity should contribute to a better understanding of the physiological and physio-pathological mechanisms of adaptation of muscle tissue.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for a knee ligamentoplasty
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients under guardianship, curatorship or deprived of liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients referred for a knee ligamentoplastyknee ligamentoplasty | Procedure or surgery | – |
Primary outcome
Determination of the mPTP calcium sensitivity mPTP
Time frame: day 0
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).
1 secondary outcome
Identification of mPTP opening discrimination factors
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruddy Richard principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the mPTP calcium sensitivity mPTP (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.