Aortic Aneurysm and DissectionMITAORTANCT05434481
MITAORTA - Role of Mitochondrial Dynamic in Aneurysm and Dissection of Ascending Thoracic Aorta
A study testing Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseases in people with Aortic Aneurysm and Dissection, run by University Hospital, Angers at 1 site in France.
Trial summary
The main objective is to compare the mitochondrial dynamic between patients operated for aneurysm of ascending aorta or type A aortic dissection (AAD) or control group Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm and Dissection
- What is being tested?
- Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseases
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2022to 23 Oct 2024
- Phase
- Interventional
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aneurysm aortic group: patients treated for an aneurysm of the ascending thoracic aorta with surgical indication according to the ESC guidelines (2014).
- Aortic dissection group: patients treated for type A acute aortic dissection or intramural hematoma of the ascending thoracic aorta in emergency.
- Control group: patients operated for aortic valve replacement (little aortic sample before closing aortotomy) or coronary artery bypass grafting which the use of a saphenous graft and the performance of a proximal anastomosis on the ascending aorta is planned
Who cannot join
- Patients under 18 years old
- Other acute aortic syndromes (penetrating ulcers, iatrogenic or traumatic dissections)
- Patients treated for aortic valve replacement in the context of infective endocarditis
- Patients treated for emergency aortic valve replacement or coronary bypass surgery**
- Pregnant, parturient and breastfeeding women
- Patients protected by an administrative or judicial measure (curatorship, guardianship)
Show all 10Show fewer
- Patients receiving psychiatric care under duress
- Adults subject to a legal protection measure.
- Patients whose the samples planned for the study could not be taken;
- Patients in the control group whose tissue sampling will not be performed.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to compare the mitochondrial dynamic between patients operated for aneurysm of ascending aorta or type A aortic dissection (AAD) or control group
Read the detailed description
In an aortic aneurysm process, the alteration of the extracellular matrix (ECM) as well as the apoptosis of the smooth muscle cells are due to inflammatory phenomena and oxydative stress, involving mitochondria which has a key place within cells.
Mitochondrial fusion and fission constitute mitochondrial dynamic and are involved in the mechanisms described above.
The alteration of mitochondrial dynamics has been demonstrated in many pathologies, in particular neurological, cancer and cardiovascular disease and generally occurs in favor of fission.
In a mouse model (FASEB J, 2021, Robert P ), the role of mitochondrial fusion has been demostrated as a protective factor against hypertension in resistance arteries and a deletion of OPA1 (optic Atrophy 1) fusion protein may lead to aneurysm until aortic dissection. The results of this experimental study suggest a role of the alteration of mitochondrial dynamic in the development of aneurysm and aortic dissection.
- Conditions
- Aortic Aneurysm and Dissection
- Being tested
- Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseases
- Keywords
- extracellular matrix, cell survival, oxydative stress, mitochondrial fusion, metabolomic profiling of aortic aneurym, metabolomic profilng of aortic dissection
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseasesOther
- For each patient: a segment of aorta will be sampled and cutted into 4 parts
- 1 fragment placed in a Falcon tube containing DMEM (Dulbecco's Modified Eagle Medium, Thermo Fisher®), temporarily stored at + 4°C, for primary culture of smooth muscle cells will allow analysis of the mitochondrial network.
- 1 fragment placed in a Falcon tube containing Allprotect Tissue Reagent (QIAGEN®), stored at -80°C for gene (RT-PCR) and protein (Western Blot) analysis.
- 2 fragments each placed in dry cryotube stored at - 80°C will be used for metabolomic analysis.
- For each patient, 2 arterial blood samples will be collected before general anaesthesia
- One tube of whole blood stored at -80°C for metabolomic analysis.
- One tube of blood stored at -80°C for plasma cytokines
| Study group | Role | What they receive |
|---|---|---|
| Aneurysm group | Active comparator | Patients operated for aneurysm of the ascending aorta according the guidelines on the diagnosis and treatment of aortic diseases (European Society of Cardiology - 2014). Receives: Other: Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseases |
| Type A aortic dissection group | Active comparator | Patients operated for type A aortic dissection according the guidelines on the diagnosis and treatment of aortic diseases (European Society of Cardiology - 2014). Receives: Other: Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseases |
| Control group | Sham comparator | Patients without aortic aneurysm or aortic dissection operated for aortic valve replacement (AVR) and/or coronary artery bypass with a saphenous vein graft for proximal aortic anastomosis to collect the aortic sample. For patients operated for AVR, an aortic sample will be collected before closing the aorta. Receives: Other: Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of tissue expression of the genes and coding for the proteins (Optic Atrophy 1) OPA1
Level expression of, (Optic Atrophy 1) OPA1 by RT-qPCR
Measured: 1 month
Level of tissue expression of the genes and coding for the proteins MFN1 (Mitofusin 1)
Level expression of MFN1 (Mitofusin 1) by RT-qPCR
Measured: 1 month
Level of tissue expression of the genes and coding for the proteins MFN2 (Mitofusin 2)
Level expression of MFN2 (Mitofusin 2) by RT-qPCR
Measured: 1 month
Level of tissue expression of the genes and coding for the proteins Fis1
Level expression of Fis1 by RT-qPCR
Measured: 1 month
Level of tissue expression of the genes and coding for the proteins Drp1
Level expression of Drp1 by RT-qPCR
Measured: 1 month
Level of tissue expression of the genes and coding for the proteins Nfr1
Level expression of Nfr1 by RT-qPCR
Measured: 1 month
Level of tissue expression of the genes and coding for the proteins Tfam
Level expression of Tfam by RT-qPCR
Measured: 1 month
Level of tissue expression of the genes and coding for the proteins PGC1⍺
Level expression of PGC1⍺ by RT-qPCR
Measured: 1 month
Analysis of mitochondrial network
To analyze the mitochondrial network, vascular smooth muscle cells will be extracted from the wall of aorta samples and seeded in Petri dish. When 80% confluence is obtained, cells will be incubated with a green fluorescent marker (Mitotacker Green Probes) and 3D fluorescence microscopy will be used. Analysis of mitochondrial network will be done after characterization of mitochondrial shapes and distribution in the different aorta samples.
Measured: 1 month
Secondary outcomes (16)
Protein of remodelling and constitution of extracellular matrix: Metalloprotease MMp2
Level expression of Metalloprotease MMp2 by western blot
Measured: 1 month
Proteins of remodelling and constitution of extracellular matrix: Timp 1/2
Level expression of Timp 1/2 by western blot
Measured: 1 month
Proteins of remodelling and constitution of extracellular matrix: Collagene I/III
Level expression of Collagene I/III by western blot
Measured: 1 month.
Protein of remodelling and constitution of extracellular matrix: Elastine
Level expression of Elastine by western blot
Measured: 1 month
Proteins of survival cell: Bcl2/Bax
Level expression of Bcl2/Bax by western blot
Measured: 1 month
Proteins of survival cell: Cytochrome C
Level expression of Cytochrome C by western blot
Measured: 1 month
Proteins of oxydative stress: NADPH
Level expression of NADPH by western blot
Measured: 1 month
Proteins of oxydative stress: OxyD
Level expression of OxyD by western blot
Measured: 1 month
Proteins of oxydative stress: Sod 1/2
Level expression of Sod 1/2 by western blot
Measured: 1 month
Proteins of Smooth Muscle Cell reactivity: Myh11
Level expression of Myh11 by western blot
Measured: 1 month
Proteins of Smooth Muscle Cell reactivity: Acta 2
Level expression of Acta 2 by western blot
Measured: 1 month
Proteins of Smooth Muscle Cell reactivity: MLC20
Level expression of MLC20 by western blot
Measured: 1 month
Proteins of Smooth Muscle Cell reactivity: Rock1
Level expression of Rock1 by western blot
Measured: 1 month
Proteins of Smooth Muscle Cell reactivity: Rhoa
Level expression of Rhoa by western blot
Measured: 1 month
Analysis of Plasma Metabolomes
154 metabolites will be measured in plasma samples. Plasma data blocks will be submitted to multiblock orthogonal component analysis (MOCA) after normalizing concentrations of plasma samples by their weights.
Measured: 2 years
Analysis of Aorta Metabolomes
136 metabolites will be measured in plasma samples. Plasma data blocks will be submitted to multiblock orthogonal component analysis (MOCA) after normalizing concentrations of aorta samples by their weights.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start7 Sep 2022
- Primary completion23 Oct 2023
- Study completion23 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm and DissectionStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Aneurysm and Dissection of Ascending Thoracic Aorta
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434481
- Sponsor's protocol ID
- 2022-A00719-34
- Acronym
- MITAORTA
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2022
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be collected in a coded manner: first letter of the surname, first letter of the patient's first name, serial number of inclusion in the center by the physicians investigating the study in the electronic observation notebook managed by the DRCI of University Hospital of Angers
Publications
Trabado S, Al-Salameh A, Croixmarie V, Masson P, Corruble E, Feve B, Colle R, Ripoll L, Walther B, Boursier-Neyret C, Werner E, Becquemont L, Chanson P. The human plasma-metabolome: Reference values in 800 French healthy volunteers; impact of cholesterol, gender and age. PLoS One. 2017 Mar 9;12(3):e0173615. doi: 10.1371/journal.pone.0173615. eCollection 2017.
PubMed 28278231Robert P, Nguyen PMC, Richard A, Grenier C, Chevrollier A, Munier M, Grimaud L, Proux C, Champin T, Lelievre E, Sarzi E, Vessieres E, Henni S, Prunier D, Reynier P, Lenaers G, Fassot C, Henrion D, Loufrani L. Protective role of the mitochondrial fusion protein OPA1 in hypertension. FASEB J. 2021 Jul;35(7):e21678. doi: 10.1096/fj.202000238RRR.
PubMed 34133045Toda M, Yamamoto K, Shimizu N, Obi S, Kumagaya S, Igarashi T, Kamiya A, Ando J. Differential gene responses in endothelial cells exposed to a combination of shear stress and cyclic stretch. J Biotechnol. 2008 Jan 20;133(2):239-44. doi: 10.1016/j.jbiotec.2007.08.009. Epub 2007 Aug 9.
PubMed 17850909Archer SL. Mitochondrial dynamics--mitochondrial fission and fusion in human diseases. N Engl J Med. 2013 Dec 5;369(23):2236-51. doi: 10.1056/NEJMra1215233. No abstract available.
PubMed 24304053Piquereau J, Caffin F, Novotova M, Prola A, Garnier A, Mateo P, Fortin D, Huynh le H, Nicolas V, Alavi MV, Brenner C, Ventura-Clapier R, Veksler V, Joubert F. Down-regulation of OPA1 alters mouse mitochondrial morphology, PTP function, and cardiac adaptation to pressure overload. Cardiovasc Res. 2012 Jun 1;94(3):408-17. doi: 10.1093/cvr/cvs117. Epub 2012 Mar 8.
PubMed 22406748Le Page S, Niro M, Fauconnier J, Cellier L, Tamareille S, Gharib A, Chevrollier A, Loufrani L, Grenier C, Kamel R, Sarzi E, Lacampagne A, Ovize M, Henrion D, Reynier P, Lenaers G, Mirebeau-Prunier D, Prunier F. Increase in Cardiac Ischemia-Reperfusion Injuries in Opa1+/- Mouse Model. PLoS One. 2016 Oct 10;11(10):e0164066. doi: 10.1371/journal.pone.0164066. eCollection 2016.
PubMed 27723783
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MITAORTA - Role of Mitochondrial Dynamic in Aneurysm and Dissection of Ascending Thoracic Aorta
- ClinicalTrials.gov ID
- NCT05434481
- Acronym / sponsor ID
- MITAORTA / 2022-A00719-34
- Conditions
- Aortic Aneurysm and Dissection
- Keywords
- extracellular matrix, cell survival, oxydative stress, mitochondrial fusion, metabolomic profiling of aortic aneurym, metabolomic profilng of aortic dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Fondation de l'Avenir
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2024 (estimated)
- First posted
- 28 Jun 2022 (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.
The main objective is to compare the mitochondrial dynamic between patients operated for aneurysm of ascending aorta or type A aortic dissection (AAD) or control group
Detailed description
In an aortic aneurysm process, the alteration of the extracellular matrix (ECM) as well as the apoptosis of the smooth muscle cells are due to inflammatory phenomena and oxydative stress, involving mitochondria which has a key place within cells.
Mitochondrial fusion and fission constitute mitochondrial dynamic and are involved in the mechanisms described above.
The alteration of mitochondrial dynamics has been demonstrated in many pathologies, in particular neurological, cancer and cardiovascular disease and generally occurs in favor of fission.
In a mouse model (FASEB J, 2021, Robert P ), the role of mitochondrial fusion has been demostrated as a protective factor against hypertension in resistance arteries and a deletion of OPA1 (optic Atrophy 1) fusion protein may lead to aneurysm until aortic dissection. The results of this experimental study suggest a role of the alteration of mitochondrial dynamic in the development of aneurysm and aortic dissection.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Aneurysm and Dissection of Ascending Thoracic Aorta
| Arm | Type | Receives |
|---|---|---|
| Aneurysm group | Active comparator | Other: Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseasesPatients operated for aneurysm of the ascending aorta according the guidelines on the diagnosis and treatment of aortic diseases (European Society of Cardiology - 2014). |
| Type A aortic dissection group | Active comparator | Other: Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseasesPatients operated for type A aortic dissection according the guidelines on the diagnosis and treatment of aortic diseases (European Society of Cardiology - 2014). |
| Control group | Sham comparator | Other: Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseasesPatients without aortic aneurysm or aortic dissection operated for aortic valve replacement (AVR) and/or coronary artery bypass with a saphenous vein graft for proximal aortic anastomosis to collect the aortic sample. For patients operated for AVR, an aortic sample will be collected before closing the aorta. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aneurysm aortic group: patients treated for an aneurysm of the ascending thoracic aorta with surgical indication according to the ESC guidelines (2014).
- Aortic dissection group: patients treated for type A acute aortic dissection or intramural hematoma of the ascending thoracic aorta in emergency.
- Control group: patients operated for aortic valve replacement (little aortic sample before closing aortotomy) or coronary artery bypass grafting which the use of a saphenous graft and the performance of a proximal anastomosis on the ascending aorta is planned
Key exclusion criteria (10 listed)
- Patients under 18 years old
- Other acute aortic syndromes (penetrating ulcers, iatrogenic or traumatic dissections)
- Patients treated for aortic valve replacement in the context of infective endocarditis
- Patients treated for emergency aortic valve replacement or coronary bypass surgery**
- Pregnant, parturient and breastfeeding women
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 |
|---|---|---|
| Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseases* For each patient: a segment of aorta will be sampled and cutted into 4 parts * 1 fragment placed in a Falcon tube containing DMEM (Dulbecco's Modified Eagle Medium, Thermo Fisher®), temporarily stored at + 4°C, for primary culture of smooth muscle cells will allow analysis of the mitochondrial network. * 1 fragment placed in a Falcon tube containing Allprotect Tissue Reagent (QIAGEN®), stored at -80°C for gene (RT-PCR) and protein (Western Blot) analysis. * 2 fragments each placed in dry cryotube stored at - 80°C will be used for metabolomic analysis. * For each patient, 2 arterial blood samples will be collected before general anaesthesia * One tube of whole blood stored at -80°C for metabolomic analysis. * One tube of blood stored at -80°C for plasma cytokines | Other | Aneurysm group, Control group, Type A aortic dissection group |
Primary outcome
Level of tissue expression of the genes and coding for the proteins (Optic Atrophy 1) OPA1
Time frame: 1 month
Level expression of, (Optic Atrophy 1) OPA1 by RT-qPCR
Level of tissue expression of the genes and coding for the proteins MFN1 (Mitofusin 1)
Time frame: 1 month
Level expression of MFN1 (Mitofusin 1) by RT-qPCR
Level of tissue expression of the genes and coding for the proteins MFN2 (Mitofusin 2)
Time frame: 1 month
Level expression of MFN2 (Mitofusin 2) by RT-qPCR
Level of tissue expression of the genes and coding for the proteins Fis1
Time frame: 1 month
Level expression of Fis1 by RT-qPCR
Level of tissue expression of the genes and coding for the proteins Drp1
Time frame: 1 month
Level expression of Drp1 by RT-qPCR
Level of tissue expression of the genes and coding for the proteins Nfr1
Time frame: 1 month
Level expression of Nfr1 by RT-qPCR
Level of tissue expression of the genes and coding for the proteins Tfam
Time frame: 1 month
Level expression of Tfam by RT-qPCR
Level of tissue expression of the genes and coding for the proteins PGC1⍺
Time frame: 1 month
Level expression of PGC1⍺ by RT-qPCR
Analysis of mitochondrial network
Time frame: 1 month
To analyze the mitochondrial network, vascular smooth muscle cells will be extracted from the wall of aorta samples and seeded in Petri dish. When 80% confluence is obtained, cells will be incubated with a green fluorescent marker (Mitotacker Green Probes) and 3D fluorescence microscopy will be used. Analysis of mitochondrial network will be done after characterization of mitochondrial shapes and distribution in the different aorta samples.
16 secondary outcomes
Protein of remodelling and constitution of extracellular matrix: Metalloprotease MMp2
Time frame: 1 month
Proteins of remodelling and constitution of extracellular matrix: Timp 1/2
Time frame: 1 month
Proteins of remodelling and constitution of extracellular matrix: Collagene I/III
Time frame: 1 month.
Protein of remodelling and constitution of extracellular matrix: Elastine
Time frame: 1 month
Proteins of survival cell: Bcl2/Bax
Time frame: 1 month
Proteins of survival cell: Cytochrome C
Time frame: 1 month
Proteins of oxydative stress: NADPH
Time frame: 1 month
Proteins of oxydative stress: OxyD
Time frame: 1 month
Proteins of oxydative stress: Sod 1/2
Time frame: 1 month
Proteins of Smooth Muscle Cell reactivity: Myh11
Time frame: 1 month
Proteins of Smooth Muscle Cell reactivity: Acta 2
Time frame: 1 month
Proteins of Smooth Muscle Cell reactivity: MLC20
Time frame: 1 month
Proteins of Smooth Muscle Cell reactivity: Rock1
Time frame: 1 month
Proteins of Smooth Muscle Cell reactivity: Rhoa
Time frame: 1 month
Analysis of Plasma Metabolomes
Time frame: 2 years
Analysis of Aorta Metabolomes
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Background: PubMed 28278231Trabado S, Al-Salameh A, Croixmarie V, Masson P, Corruble E, Feve B, Colle R, Ripoll L, Walther B, Boursier-Neyret C, Werner E, Becquemont L, Chanson P. The human plasma-metabolome: Reference values in 800 French healthy volunteers; impact of cholesterol, gender and age. PLoS One. 2017 Mar 9;12(3):e0173615. doi: 10.1371/journal.pone.0173615. eCollection 2017.
- Results publication: PubMed 34133045Robert P, Nguyen PMC, Richard A, Grenier C, Chevrollier A, Munier M, Grimaud L, Proux C, Champin T, Lelievre E, Sarzi E, Vessieres E, Henni S, Prunier D, Reynier P, Lenaers G, Fassot C, Henrion D, Loufrani L. Protective role of the mitochondrial fusion protein OPA1 in hypertension. FASEB J. 2021 Jul;35(7):e21678. doi: 10.1096/fj.202000238RRR.
- Results publication: PubMed 17850909Toda M, Yamamoto K, Shimizu N, Obi S, Kumagaya S, Igarashi T, Kamiya A, Ando J. Differential gene responses in endothelial cells exposed to a combination of shear stress and cyclic stretch. J Biotechnol. 2008 Jan 20;133(2):239-44. doi: 10.1016/j.jbiotec.2007.08.009. Epub 2007 Aug 9.
- Results publication: PubMed 24304053Archer SL. Mitochondrial dynamics--mitochondrial fission and fusion in human diseases. N Engl J Med. 2013 Dec 5;369(23):2236-51. doi: 10.1056/NEJMra1215233. No abstract available.
- Results publication: PubMed 22406748Piquereau J, Caffin F, Novotova M, Prola A, Garnier A, Mateo P, Fortin D, Huynh le H, Nicolas V, Alavi MV, Brenner C, Ventura-Clapier R, Veksler V, Joubert F. Down-regulation of OPA1 alters mouse mitochondrial morphology, PTP function, and cardiac adaptation to pressure overload. Cardiovasc Res. 2012 Jun 1;94(3):408-17. doi: 10.1093/cvr/cvs117. Epub 2012 Mar 8.
- Results publication: PubMed 27723783Le Page S, Niro M, Fauconnier J, Cellier L, Tamareille S, Gharib A, Chevrollier A, Loufrani L, Grenier C, Kamel R, Sarzi E, Lacampagne A, Ovize M, Henrion D, Reynier P, Lenaers G, Mirebeau-Prunier D, Prunier F. Increase in Cardiac Ischemia-Reperfusion Injuries in Opa1+/- Mouse Model. PLoS One. 2016 Oct 10;11(10):e0164066. doi: 10.1371/journal.pone.0164066. eCollection 2016.
- Individual participant dataSharing planned: No. The data will be collected in a coded manner: first letter of the surname, first letter of the patient's first name, serial number of inclusion in the center by the physicians investigating the study in the electronic observation notebook managed by the DRCI of University Hospital of Angers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitochondrial dynamic analysis in the aorta samples and metabolomic profiling in the aortic diseases in people with Aortic Aneurysm and Dissection, run by University Hospital, Angers 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 3 inclusion and 10 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 11 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of tissue expression of the genes and coding for the proteins (Optic Atrophy 1) OPA1 (time frame: 1 month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05434481, which also lists 6 linked publications.
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 11 Jun 2024.