AneurysmANEUVISMNCT05189041
Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging
A study testing Aneurysmal pulsation in functional MRI in people with Aneurysm, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Stroke is the leading cause of disability in France with 130,000 cases per year, 20% of strokes being hemorrhagic, with a majority of intracranial aneurysm rupture (80%). Each year, 6000 meningeal hemorrhages (MHA) caused by cerebral aneurysm rupture are reported in France: 40% of patients die within the first month… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aneurysm
- What is being tested?
- Aneurysmal pulsation in functional MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 2017
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age limits to > 18 years
- Collection of the informed consent (patient or legal representant)
- Affiliation or recipient with the mode of social security
- Groupe anévrysme rompu
- Patient porteur d'un anévrysme rompu
- Groupe anévrysme non rompu
- Patient porteur d'un anévrysme non rompu
Who cannot join
- Subject presenting contraindications in MRI (Ferromagnetic foreign bodies, pace-maker …)
- Claustrophobia
- Women pregnant or Breast-feeding
- Patient participating in an other study
- Patient have participated in a study in the 3 months before the inclusion
- In period of exclusion relative to another protocol
Show all 9Show fewer
- Person with majority age protected by the law (supervision or trusteeship).
- Patient not reading the french language
- Patient or representant for whom it impossible to give accurate informations
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is the leading cause of disability in France with 130,000 cases per year, 20% of strokes being hemorrhagic, with a majority of intracranial aneurysm rupture (80%). Each year, 6000 meningeal hemorrhages (MHA) caused by cerebral aneurysm rupture are reported in France: 40% of patients die within the first month and 30% are left with severe and permanent disability. Intracranial aneurysms are present in 2 to 6% of the population and only about 0.5% of them will rupture. Given the human and economic costs associated with this disease, systematic medical screening for intracranial aneurysms could be useful. However, the operative risk of endovascular treatment remains non-zero (around 1%) and could be proposed only to a selected population of aneurysms at risk of rupture. The absence of diagnostic criteria for aneurysmal vulnerability does not allow for the moment to consider screening for this disease, which continues to strike without warning a young and active population.
Nevertheless, access to brain imaging allows the detection of an increasing number of intracranial aneurysms. The question of preventive treatment then arises and is still a difficult point discussed by neurosurgeons / neurointerventionists based on general epidemiological data difficult to apply to an individual.
- Conditions
- Aneurysm
- Being tested
- Aneurysmal pulsation in functional MRI
- Keywords
- aneurysm
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aneurysmal pulsation in functional MRIOther
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm
| Study group | Role | What they receive |
|---|---|---|
| Ruptured Cerebral Aneurysm | Other | Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm Receives: Other: Aneurysmal pulsation in functional MRI |
| Non Ruptured Cerebral Aneurysm | Other | Quantify the aneurysmal pulsation in functional MRI on the patient with Non Ruptured Cerebral Aneurysm Receives: Other: Aneurysmal pulsation in functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the aneurysmal pulsation in functional MRI
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm or Non ruptured Aneurysm
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study startJun 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VINCENT COSTALAT, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189041
- Sponsor's protocol ID
- 9364
- Acronym
- ANEUVISM
- Status last verified
- Dec 2021
- First submitted
- 27 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging
- ClinicalTrials.gov ID
- NCT05189041
- Acronym / sponsor ID
- ANEUVISM / 9364
- Conditions
- Aneurysm
- Keywords
- aneurysm
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Jan 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.
Stroke is the leading cause of disability in France with 130,000 cases per year, 20% of strokes being hemorrhagic, with a majority of intracranial aneurysm rupture (80%). Each year, 6000 meningeal hemorrhages (MHA) caused by cerebral aneurysm rupture are reported in France: 40% of patients die within the first month and 30% are left with severe and permanent disability. Intracranial aneurysms are present in 2 to 6% of the population and only about 0.5% of them will rupture. Given the human and economic costs associated with this disease, systematic medical screening for intracranial aneurysms could be useful. However, the operative risk of endovascular treatment remains non-zero (around 1%) and could be proposed only to a selected population of aneurysms at risk of rupture. The absence of diagnostic criteria for aneurysmal vulnerability does not allow for the moment to consider screening for this disease, which continues to strike without warning a young and active population.
Nevertheless, access to brain imaging allows the detection of an increasing number of intracranial aneurysms. The question of preventive treatment then arises and is still a difficult point discussed by neurosurgeons / neurointerventionists based on general epidemiological data difficult to apply to an individual.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruptured Cerebral Aneurysm | Other | Other: Aneurysmal pulsation in functional MRIQuantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm |
| Non Ruptured Cerebral Aneurysm | Other | Other: Aneurysmal pulsation in functional MRIQuantify the aneurysmal pulsation in functional MRI on the patient with Non Ruptured Cerebral Aneurysm |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age limits to > 18 years
- Collection of the informed consent (patient or legal representant)
- Affiliation or recipient with the mode of social security
- Patient porteur d'un anévrysme rompu
- Patient porteur d'un anévrysme non rompu
Key exclusion criteria (9 listed)
- Subject presenting contraindications in MRI (Ferromagnetic foreign bodies, pace-maker …)
- Claustrophobia
- Women pregnant or Breast-feeding
- Patient participating in an other study
- Patient have participated in a study in the 3 months before the inclusion
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 |
|---|---|---|
| Aneurysmal pulsation in functional MRIQuantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm | Other | Non Ruptured Cerebral Aneurysm, Ruptured Cerebral Aneurysm |
Primary outcome
Quantify the aneurysmal pulsation in functional MRI
Time frame: 1 day
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm or Non ruptured Aneurysm
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
VINCENT COSTALAT study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aneurysmal pulsation in functional MRI in people with Aneurysm, run by University Hospital, Montpellier 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Jan 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?
The study was stopped early. 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?
Quantify the aneurysmal pulsation in functional MRI (time frame: 1 day). 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 12 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.