MRI Analysis in the Growth of Cerebral Aneurysms (EPICAVC)

November 22, 2024 updated by: CHU de Reims

4D-MRI Morphological Study of Local Growth in Cerebral Aneurysms

An intracranial aneurysm is defined as a localized dilatation of the cerebral arteries, which can potentially lead to rupture and subsequent hemorrhagic stroke. The mechanisms by which aneurysms develop and grow remain unknown. The objective of this project is to utilize MRI, a routine non-invasive examination for detecting and following up aneurysms, to identify visually and quantitatively an aneurysm growth and relevant biomarkers that can predict the risk of aneurysm development.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

An intracranial aneurysm is defined as a malformation of the cerebral arteries, which is characterized by a focal dilatation of the arterial wall.

The prevalence of intracranial aneurysms in the general population is estimated to be between 3% and 6%, as reported in the literature. Although the rupture rate is relatively low, at approximately 1-2% per year per aneurysm, this risk is increased if the aneurysm is growing. The morbi-mortality rates associated with meningeal or subarachnoid hemorrhage are high, with an estimated 60% mortality rate within three months and 30% of patients remaining permanently disabled. It is therefore imperative to monitor the evolution of aneurysms in order to assess the risk of complications and guide therapeutic decisions.

The mechanism(s) of aneurysm formation and growth remain unknown. Aneurysms form in a zone of weakness in the artery wall as a result of hemodynamic variations.

Methods of risk stratification and therapeutic planning (endovascular treatment (coil) or surgical treatment (clip)) are currently based solely on empirical and statistical parameters such as the size or shape of the aneurysm, the patient's smoking habits or alcoholism.

The fundamental principle underlying the treatment of cerebral aneurysms with the objective of reducing the risk of long-term rupture is the exclusion of the aneurysm from the arterial circulation. This confirm the impact of hemodynamics on the risk of aneurysm rupture.

Although arteriography remains the gold standard for follow-up of aneurysms, it is an invasive and irradiative examination that is increasingly being replaced by a non-invasive routine exam, Magnetic Resonance Imaging (MRI).

Currently, there is no consensus regarding the indications for the treatment of unruptured intracranial aneurysms, which are generally asymptomatic. Successful outcome of the project would improve physical understanding of aneurysmal pathology, enabling the decision-making process regarding treatment to be adapted to the specific characteristics of the aneurysm in question. This would provide additional arguments for proposing or not proposing expensive endovascular treatment of aneurysms, which is often proposed as a first-line treatment.

Study Type

Interventional

Enrollment (Estimated)

281

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 Contact

Study Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

inclusion criteria:

  • Patients with one or more unruptured intracranial aneurysms followed up at the participating center. Patients may have other ruptured and/or treated aneurysms
  • Patient older than 18 years
  • Patient consenting to participate to the study
  • Patient enrolled in the national healthcare insurance program

exclusion criteria:

  • Patients who have already received surgical or endovascular treatment for all their aneurysm(s), or who are due to receive such treatment in less than 2 months.
  • Patients with only ruptured aneurysm(s)
  • Patients with arteriovenous malformations (treated or untreated)
  • Patients with a contraindication to MRI
  • Patients with an allergy to one of the contrast agents (Iodixanol, Gadoteric acid)
  • Pregnant or breast-feeding patients
  • Patients protected by law.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with unruptured and untreated aneurysms
Patients in radiology for the first diagnostic evaluation or the follow-up of unruptured and untreated aneurysms.
Other: Additional 4D Flow MRI or additional 4D Flow sequence
Additional 4D Flow MRI or additional 4D Flow sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of the shape of the aneurysm
Time Frame: At 3 years
Millimetric quantification of the three-dimensional evolution of the shape of the aneurysm sac, calculated using a computer algorithm
At 3 years

Collaborators and Investigators

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

Sponsor

CHU de Reims

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2032

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO24101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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