Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging

NCT ID: NCT05189041

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-12-31

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.

Conditions

Aneurysm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ruptured Cerebral Aneurysm

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

Group Type: OTHER

Aneurysmal pulsation in functional MRI

Intervention Type: OTHER

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

Non Ruptured Cerebral Aneurysm

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

Group Type: OTHER

Aneurysmal pulsation in functional MRI

Intervention Type: OTHER

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

Interventions

Aneurysmal pulsation in functional MRI

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

VINCENT COSTALAT

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

COSTALAT

Montpellier, , France

Countries

France

Other Identifiers

9364

Identifier Type: -

Identifier Source: org_study_id