Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging (ANEUVISM)
Primary Purpose
Aneurysm
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Aneurysmal pulsation in functional MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Aneurysm focused on measuring aneurysm
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- COSTALAT
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Ruptured Cerebral Aneurysm
Non Ruptured Cerebral Aneurysm
Arm Description
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm
Quantify the aneurysmal pulsation in functional MRI on the patient with Non Ruptured Cerebral Aneurysm
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05189041
First Posted
December 27, 2021
Last Updated
January 11, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT05189041
Brief Title
Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging
Acronym
ANEUVISM
Official Title
Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm
Keywords
aneurysm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ruptured Cerebral Aneurysm
Arm Type
Other
Arm Description
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm
Arm Title
Non Ruptured Cerebral Aneurysm
Arm Type
Other
Arm Description
Quantify the aneurysmal pulsation in functional MRI on the patient with Non Ruptured Cerebral Aneurysm
Intervention Type
Other
Intervention Name(s)
Aneurysmal pulsation in functional MRI
Intervention Description
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm
Primary Outcome Measure Information:
Title
Quantify the aneurysmal pulsation in functional MRI
Description
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm or Non ruptured Aneurysm
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VINCENT COSTALAT
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
COSTALAT
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging
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