Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging

Not Applicable

Terminated

• Conditions: Aneurysm
• Interventions: Other: Aneurysmal pulsation in functional MRI

• Registration Number: NCT05189041
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2021-12
• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2022-01-11
• Last Update Submitted: 2022-01-11
• Study First Posted: 2022-01-12
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ruptured Cerebral Aneurysm	Aneurysmal pulsation in functional MRI	Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm
Non Ruptured Cerebral Aneurysm	Aneurysmal pulsation in functional MRI	Quantify the aneurysmal pulsation in functional MRI on the patient with Non Ruptured Cerebral Aneurysm

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

COSTALAT; 🇫🇷 Montpellier, France