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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Terminated

Conditions

Aneurysm

Treatments

Other: Aneurysmal pulsation in functional MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT05189041
9364 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups

Ruptured Cerebral Aneurysm
Other group
Description:
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm
Treatment:
Other: Aneurysmal pulsation in functional MRI
Non Ruptured Cerebral Aneurysm
Other group
Description:
Quantify the aneurysmal pulsation in functional MRI on the patient with Non Ruptured Cerebral Aneurysm
Treatment:
Other: Aneurysmal pulsation in functional MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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