MedDataX Logo

Leucoaraiosis and Multimodal MRI With Fingerprinting Technique

NCT ID: NCT06181981

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-14

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Leukoaraiosis (LA) corresponds to an alteration of the encephalic white matter, linked to chronic hypoxia. Its pathophysiology, which has been partially elucidated, is underpinned by chronic changes in the walls of small-caliber perforating arteries, leading to chronic hypoperfusion of the white matter, associated with dysfunction of the blood-brain barrier. In affected areas, this process leads to myelin rarefaction, axonal loss, perivascular alterations and the appearance of cavitation zones. Its existence is mainly linked to the presence of vascular risk factors, most notably arterial hypertension.

MR fingerprinting is an innovative Magnetic resonance Imaging (MRI) technique allowing to obtain a multiparametric MRI sequence in a non-invasively way and in a single acquisition, generating not only multiple contrasts, but also absolute longitudinal relaxation time (T1) and transverse relaxation time (T2) mappings (T1 and T2 mapping). However, the prognostic role of these T2 values, in terms of ischemic, hemorrhagic and cognitive risk, has never been studied. The objective of this study is to study and compare changes in T1 and T2 values of White Matter Hyperintensities (WMH) and Normal Appearing White Matter (NAWM) in subjects with LA.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukoaraiosis Magnetic Resonance Imaging

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Leukoaraiosis Magnetic Resonance Imaging White Matter Hyperintensities (WMH) Normal Appearing White Matter (NAWM)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

incidental Leukoaraiosis (LA)

Eligible patients in the incidental LA group will be pre-identified by the radiologist at the time of the 3T MRI or CT scan, and recruited by the neurologist at their first routine neurology consultation in the days following the MRI.

MRI fingerprinting

Intervention Type DIAGNOSTIC_TEST

This method allows to get quantitative magnetic resonance imaging for the simultaneous measurement of multiple tissue properties in a single, time-efficient acquisition

LA and ischemic stroke

Eligible patients in the LA + ischemic stroke group will be recruited by the neurologist during hospitalization for ischemic stroke

MRI fingerprinting

Intervention Type DIAGNOSTIC_TEST

This method allows to get quantitative magnetic resonance imaging for the simultaneous measurement of multiple tissue properties in a single, time-efficient acquisition

LA and intracerebral hemorrhage

Eligible patients in the LA + intracerebral hemorrhage group will be recruited by the neurologist during hospitalization

MRI fingerprinting

Intervention Type DIAGNOSTIC_TEST

This method allows to get quantitative magnetic resonance imaging for the simultaneous measurement of multiple tissue properties in a single, time-efficient acquisition

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI fingerprinting

This method allows to get quantitative magnetic resonance imaging for the simultaneous measurement of multiple tissue properties in a single, time-efficient acquisition

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient over 40 years of age
* Suffering from leucoaraiosis
* Diagnosed via cerebral MRI or CT scan performed by the St Philibert Hospital imaging department

For the groups:

* incidental LA (patients included in group 1): on the MRI, FLAIR images showed the presence of hyperintense white matter lesions, assessed at a minimum FAZEKAS grade 2+2, the origin of which was related to small artery disease discovered incidentally or during acute management in GHICL's neurovascular intensive care unit. The CT scan revealed hypodense patches of deep periventricular white matter, also of minimal Fazekas grade 2+2.
* LA and ischemia (patients included in group 2): on the MRI, FLAIR images show the presence of hyperintense white matter lesions with an extent assessed at a minimum grade of FAZEKAS 2+2: their origin is related to small artery disease discovered during acute management of cerebral ischemia in the GHICL's Neurovascular Intensive Care Unit.
* LA and cerebral hemorrhage (patients included in group 3): on the MRI, FLAIR images show the presence of hyperintense white matter lesions of minimal FAZEKAS grade 2+2: their origin is related to small artery disease discovered during the acute management of a cerebral hemorrhage, in the GHICL's Neurovascular Intensive Care Unit.

Exclusion Criteria

* Claustrophobia preventing MRI scan
* MRI contraindication
* White matter lesions with diagnosis not formally established, doubtful, multifactorial or related to a differential diagnosis
* Patients with dementia or pathology that precludes longitudinal follow-up
* Institutionalized patients
* Agitation not allowing MRI to be performed
* Pregnant women
* Patients under guardianship
* Patients objecting the use of their data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role collaborator

Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sébastien VERCLYTTE, MD

Role: STUDY_DIRECTOR

Groupement des Hopitaux de l'institut catholique de Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Grupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marie Paule LEBITASY, MD

Role: CONTACT

Phone: 00 33 3 20 22 57 41

Email: [email protected]

Domitille TRISTRAM

Role: CONTACT

Phone: 00 33 3 20 22 57 37

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lebitasy Marie-Paule, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RNIPH-2022-03

Identifier Type: -

Identifier Source: org_study_id