Compliance, Magnetic Resonance Imaging, Biaxial Testing, Elastic ModulusNCT05252143
Evaluation of Elastic Properties of Ascending Aorta
An observational study of Compliance, Magnetic Resonance Imaging, Biaxial Testing, Elastic Modulus, run by Centre Hospitalier La Chartreuse at 1 site in France.
Trial summary
The aim of our study is to assess a correlation between local patient specific elastic modulus distribution of the ascending aorta from a biaxial tensile test and MRI measurements of the elastic properties of the aorta. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compliance, Magnetic Resonance Imaging, Biaxial Testing, Elastic Modulus
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 31 Dec 2024
- 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: 200 patients operated in cardiac surgery unit of Dijon hospital starting in December 2018
Who may be able to join
- patient referred for ascending aorta aneurysm requiering replacement
- elective patient
Who cannot join
- claustrophobia
- contraindication to performing cardiac MRI
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Dijon University Hospital
Dijon, 21000
Aline LAUBRIET, PhD, aline.laubriet@chu-dijon.fr
About this study
Official title: Elastic Properties of the Ascending Aorta Evaluated by Imaging and Biaxial Testing
The aim of our study is to assess a correlation between local patient specific elastic modulus distribution of the ascending aorta from a biaxial tensile test and MRI measurements of the elastic properties of the aorta.
A total of 70 patients referred for ascending aorta (AA) replacement underwent a preoperative cardiac-MRI for the evaluation the elastic properties and ascending aorta tissue was collected for biaxial testing to obtain maximum elastic modulus
Read the detailed description
Observational and prospective trial on medical data only. The patients are operated of planned aortic aneurysm without additional intervention.
The preoperative cardiac MRI are planned in standard of care.
- Medical subject headings
- Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
aortic compliance of ascending aorta (mm2/mmHg)
aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processsing
Measured: preoperative cardiac MRI performing between 1 month and 1 day before surgery
Secondary outcomes (1)
maximum elastic modulus (MPa) of ascending aorta
maximum elastic modulus is a local measurement of elastic properties which is obtained by biaxial testing
Measured: biaxial testing performing between 1 and 6 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Dec 2018
- Primary completion14 Feb 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compliance, Magnetic Resonance Imaging, Biaxial Testing, Elastic ModulusStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier La Chartreuse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252143
- Sponsor's protocol ID
- MECATHOR
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastic Properties of the Ascending Aorta Evaluated by Imaging and Biaxial Testing
- ClinicalTrials.gov ID
- NCT05252143
- Acronym / sponsor ID
- MECATHOR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier La ChartreuseUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Feb 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 aim of our study is to assess a correlation between local patient specific elastic modulus distribution of the ascending aorta from a biaxial tensile test and MRI measurements of the elastic properties of the aorta.
A total of 70 patients referred for ascending aorta (AA) replacement underwent a preoperative cardiac-MRI for the evaluation the elastic properties and ascending aorta tissue was collected for biaxial testing to obtain maximum elastic modulus
Detailed description
Observational and prospective trial on medical data only. The patients are operated of planned aortic aneurysm without additional intervention.
The preoperative cardiac MRI are planned in standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients operated in cardiac surgery unit of Dijon hospital starting in December 2018
Key inclusion criteria (2 listed)
- patient referred for ascending aorta aneurysm requiering replacement
- elective patient
Key exclusion criteria (2 listed)
- claustrophobia
- 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.
Primary outcome
aortic compliance of ascending aorta (mm2/mmHg)
Time frame: preoperative cardiac MRI performing between 1 month and 1 day before surgery
aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processsing
1 secondary outcome
maximum elastic modulus (MPa) of ascending aorta
Time frame: biaxial testing performing between 1 and 6 hours after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
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.
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 Compliance, Magnetic Resonance Imaging, Biaxial Testing, Elastic Modulus, run by Centre Hospitalier La Chartreuse 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 2 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: status not confirmed, as of the sponsor's last update on 23 Feb 2022. 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 marie-catherine Morgant, MD (33-380293352, mariecatherine.morgant@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aortic compliance of ascending aorta (mm2/mmHg) (time frame: preoperative cardiac MRI performing between 1 month and 1 day before surgery). 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 23 Feb 2022.