Leucoaraiosis and Multimodal MRI With Fingerprinting Technique

NCT06181981 | Unknown

• 1 other identifier: RNIPH-2022-03
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukoaraiosis; Magnetic Resonance Imaging

Keywords

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

Outcome Measures

Primary Outcomes (2)

• T1 (seconds)

  T1 will be measured by three-dimensional, magnetization-prepared rapid gradient-echo (3D MP-RAGE) imaging

  30 months

• T2 (milliseconds)

  T2 will be measured by three-dimensional segmented echo-planar-imaging (3D T2 EPI)

  30 months

Secondary Outcomes (2)

• Correlation coefficient and its 95% confidence interval between WMH T1 and T2 values, and WHM lesion volume.

  30 months

• Correlation coefficient and its 95% confidence interval between T1 and T2 values of WMH and NAWM, lesion volume of WMH, and number of microbleeds

  30 months

Study Arms (3)

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.

Diagnostic Test: MRI fingerprinting

LA and ischemic stroke

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

Diagnostic Test: MRI fingerprinting

LA and intracerebral hemorrhage

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

Diagnostic Test: MRI fingerprinting

Interventions

MRI fingerprinting 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; LA and ischemic stroke; incidental Leukoaraiosis (LA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient over 40 years of age suffering from leucoaraiosis diagnosed via cerebral MRI or CT scan performed by the St Philibert Hospital (GHICL) imaging department

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead
• University Hospital, Lille: collaborator

Study Sites (1)

Grupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, 59462, France

RECRUITING

MeSH Terms

Conditions

Leukoaraiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sébastien VERCLYTTE, MD

  Groupement des Hopitaux de l'institut catholique de Lille

  STUDY DIRECTOR

Central Study Contacts

Marie Paule LEBITASY, MD

CONTACT

00 33 3 20 22 57 41; Lebitasy.Marie-Paule@ghicl.net

Domitille TRISTRAM

CONTACT

00 33 3 20 22 57 37; tristram.domitille@ghicl.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: November 14, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)