Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging

NCT05189041 | Terminated DMC

• 1 other identifier: 9364
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

aneurysm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ruptured Cerebral Aneurysm

OTHER

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

Other: Aneurysmal pulsation in functional MRI

Non Ruptured Cerebral Aneurysm

OTHER

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

Other: Aneurysmal pulsation in functional MRI

Interventions

Aneurysmal pulsation in functional MRI OTHER

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

Non Ruptured Cerebral Aneurysm; Ruptured Cerebral Aneurysm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject presenting contraindications in MRI (Ferromagnetic foreign bodies, pace-maker …)
• Claustrophobia
• Women pregnant or Breast-feeding
• Patient participating in an other study
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

COSTALAT

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• VINCENT COSTALAT

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 12, 2022

Record last verified: 2021-12

Locations

FR (1)