Aortic SurgeryNCT03817008
Changes in Elastic Properties of Descending Thoracic Aorta After Ascending Aorta Replacement
An observational study of Aortic Surgery, run by Centre Hospitalier La Chartreuse.
Trial summary
The aim of our study was to evaluate the impact of aortic root replacement by a graft on the elastic properties of the descending thoracic aorta using cardiac Magnetic Resonance Imaging (MRI) and automatic post-processing. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Aortic Surgery
- What is being tested?
- Ascending aorta replacement with graft
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 17 Jan 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 19 patients operated in Cardiac Surgery unit of DIJON Hospital between September 2014 and December 2017.
Who may be able to join
- > 18 years
- Elective patient
- Ascending aorta replacement with graft
Who cannot join
- Prior cardiac surgery
- Contraindication to performing cardiac MRI
About this study
Official title: Impact of Ascending Aorta Replacement by Graft on Elastic Properties of Descending Thoracic Aorta Evaluated by Cardiac Magnetic Resonance Imaging
The aim of our study was to evaluate the impact of aortic root replacement by a graft on the elastic properties of the descending thoracic aorta using cardiac Magnetic Resonance Imaging (MRI) and automatic post-processing.
Nineteen patients were operated on an aortic root aneurysm and a cardiac MRI allowing aortic compliance measurement was performed before and after surgery. Images were acquired with a 1.5 T MRI with only one additional sequence to a conventional aortic MRI protocol.
Read the detailed description
Observational and retrospective trial on medical data only. The patients are operated of planned aortic root aneurysm without additional intervention.
The pre and postoperative cardiac MRI are planned in standard of care.
- Conditions
- Aortic Surgery
- Being tested
- Ascending aorta replacement with graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascending aorta replacement with graftProcedure or surgery
Also called cardiac MRI
Patient with planned Ascending aorta replacement with graft
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic compliance of descending aorta (mm2/mmHg)
Aortic elastic properties of the descending aorta before and after aortic root replacement using cardiac MRI.
Aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processing.
Measured: post-operative cardiac MRI performing between 12 and 24 months
Secondary outcomes (1)
Aortic compliance of ascending aorta (mm2/mmHg)
Aortic elastic properties of the ascending aorta before and after aortic root replacement using cardiac MRI.
Aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processing.
Measured: post-operative cardiac MRI performing between 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Sep 2014
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic SurgeryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier La Chartreuse
- Sponsor type
- University, hospital or other
- Collaborators
- JAZAYERI Aline, BOUCHOT Olivier, JAZAYERI Saed, MALAPERT Ghislain, PETROSYAN Andreanik
- Responsible party
- Principal investigator, MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817008
- Sponsor's protocol ID
- MORGANT 2019
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morgant MC, Miteran J, Lin S, Laubriet A, Cochet A, Lalande A, Bouchot O. Impact of ascending aorta replacement by graft on elastic properties of descending thoracic aorta evaluated by cardiac magnetic resonance imaging. MAGMA. 2020 Oct;33(5):641-647. doi: 10.1007/s10334-020-00829-5. Epub 2020 Jan 31.
PubMed 32006121
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ascending Aorta Replacement by Graft on Elastic Properties of Descending Thoracic Aorta Evaluated by Cardiac Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03817008
- Acronym / sponsor ID
- MORGANT 2019
- Conditions
- Aortic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier La ChartreuseUniversity, hospital or other
- Collaborators
- JAZAYERI Aline, BOUCHOT Olivier, JAZAYERI Saed, MALAPERT Ghislain, PETROSYAN Andreanik
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 25 Jan 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.
The aim of our study was to evaluate the impact of aortic root replacement by a graft on the elastic properties of the descending thoracic aorta using cardiac Magnetic Resonance Imaging (MRI) and automatic post-processing.
Nineteen patients were operated on an aortic root aneurysm and a cardiac MRI allowing aortic compliance measurement was performed before and after surgery. Images were acquired with a 1.5 T MRI with only one additional sequence to a conventional aortic MRI protocol.
Detailed description
Observational and retrospective trial on medical data only. The patients are operated of planned aortic root aneurysm without additional intervention.
The pre and postoperative cardiac MRI are planned in standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 19 patients operated in Cardiac Surgery unit of DIJON Hospital between September 2014 and December 2017.
Key inclusion criteria (3 listed)
- > 18 years
- Elective patient
- Ascending aorta replacement with graft
Key exclusion criteria (2 listed)
- Prior cardiac surgery
- Contraindication to performing cardiac MRI
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 |
|---|---|---|
| Ascending aorta replacement with graftAlso: cardiac MRIPatient with planned Ascending aorta replacement with graft | Procedure or surgery | – |
Primary outcome
Aortic compliance of descending aorta (mm2/mmHg)
Time frame: post-operative cardiac MRI performing between 12 and 24 months
Aortic elastic properties of the descending aorta before and after aortic root replacement using cardiac MRI. Aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processing.
1 secondary outcome
Aortic compliance of ascending aorta (mm2/mmHg)
Time frame: post-operative cardiac MRI performing between 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Derived from this study: PubMed 32006121Morgant MC, Miteran J, Lin S, Laubriet A, Cochet A, Lalande A, Bouchot O. Impact of ascending aorta replacement by graft on elastic properties of descending thoracic aorta evaluated by cardiac magnetic resonance imaging. MAGMA. 2020 Oct;33(5):641-647. doi: 10.1007/s10334-020-00829-5. Epub 2020 Jan 31.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Surgery, run by Centre Hospitalier La Chartreuse.
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 2 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: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Aortic compliance of descending aorta (mm2/mmHg) (time frame: post-operative cardiac MRI performing between 12 and 24 months). 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 NCT03817008, which also lists 1 linked publication.
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 25 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.