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

January 11, 2022 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • COSTALAT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ruptured Cerebral Aneurysm
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm
Other: Aneurysmal pulsation in functional MRI
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm
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
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantify the aneurysmal pulsation in functional MRI
Time Frame: 1 day
Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm or Non ruptured Aneurysm
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: VINCENT COSTALAT, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

January 12, 2022

Last Update Submitted That Met QC Criteria

January 11, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9364 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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