Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging

Aneurysm Clinical Trial

— ANEUVISM  

Official title:

Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05189041
• Other study ID #: 9364
• Status: Terminated
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2017

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm

Intervention

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

Locations

Country	Name	City	State
France	COSTALAT	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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