ANEUVISM: Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Terminated
CT.gov ID
NCT05189041
Collaborator
(none)
45
1
2
42
1.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aneurysmal pulsation in functional MRI
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging
Actual Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: Ruptured Cerebral Aneurysm

Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm

Other: Aneurysmal pulsation in functional MRI
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm

Other: Non Ruptured Cerebral Aneurysm

Quantify the aneurysmal pulsation in functional MRI on the patient with Non Ruptured Cerebral Aneurysm

Other: Aneurysmal pulsation in functional MRI
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm

Outcome Measures

Primary Outcome Measures

  1. Quantify the aneurysmal pulsation in functional MRI [1 day]

    Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm or Non ruptured Aneurysm

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 COSTALAT Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

  • Study Director: VINCENT COSTALAT, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT05189041
Other Study ID Numbers:
  • 9364
First Posted:
Jan 12, 2022
Last Update Posted:
Jan 12, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022