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

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 Overview

• Status: Terminated
• Conditions: Aneurysm
• Intervention / Treatment: Other: Aneurysmal pulsation in functional MRI

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • COSTALAT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: VINCENT COSTALAT, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: aneurysm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: 9364 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided