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TerminatedNCT05189041ANEUVISMUpdated Jan 12, 2022

Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging

An interventional study of Aneurysmal pulsation in functional MRI in Aneurysm, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-01-12.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 7 years 6 months after the study started (first participant enrolled Jun 2014, registered Dec 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aneurysm

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Keywords

  • aneurysm
03

In context

Aneurysm

959 studies on the registry are indexed under Aneurysm; 174 are open to participants now.

This study's enrollment of 45 is below the median of 72 across 462 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Other
    Ruptured Cerebral Aneurysm

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

    Other: Aneurysmal pulsation in functional MRI

  • Other
    Non Ruptured Cerebral Aneurysm

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

    Other: Aneurysmal pulsation in functional MRI

Interventions

  • OtherAneurysmal pulsation in functional MRI

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

06

What researchers measure

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

    Time frame: 1 day

07

Study locations

1 site
  • COSTALAT
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05189041
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Jan 12, 2022
Start date
Jun 2014
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Jan 12, 2022

Study contacts

VINCENT COSTALAT
study director · University Hospital, Montpellier

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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