Clinical trial NCT04298866: White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI
Official title: White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Small Vessel Diseases
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Cerebral small vessel diseases (SVD) are a very frequent group of disorders all characterized by alterations of the structure and/or function of small arteries, veins and capillaries. In these disorders, brain tissue lesions accumulate years before the occurrence of clinical symptoms which can be devastating such as stroke, cognitive disturbances and gait disorders. So far, chronic hypoperfusion was considered to be responsible for the accumulation of such lesions. However, recent results have suggested that the lesions underlying white matter hyperintensities (WMH), the most common MRI marker of SVD visible on conventional MRI in quite every subject with SVD long before the occurrence of clinical events, may depend on the considered brain area and may correspond to various mechanisms. Some WMH may even be associated with less severe clinical manifestations.The aim of the present study is to identify different types of WMH by studying 100 patients with different forms of SVD with the most advanced MRI (including ultra-high-resolution imaging at 7 Tesla, new diffusion protocol, sodium MRI, contrast-enhanced angiography and relaxometry and post-processing techniques), and post-processing techniques (machine learning, deep learning, artificial intelligence).


Eligibility criteria: Inclusion Criteria:

* Subjects or patients with MRI defined cerebral small vessel disease including different extents of white matter hyperintensities, presumably related to hypertension (30 patients), cerebral amyloid angiopathy (30 patients), CADASIL (30 patients) or any other monogenic form of cerebral small vessel disease (HTRA1 AD, COLIVA1... 10 patients)
* Age ≥ 18 years
* No dementia (MMSE \> 24 and absence of dependence in daily activities)
* No disability (modified Rankin's scale \< 2)
* No history of severe allergic reaction, in particular to gadolinium infusion
* No history of severe asthma
* No renal insufficiency (clearance \< 60 ml/mn/1.73 m2)

Exclusion Criteria:

* Contraindications to MRI
* Standard MRI of bad quality due to movement artefacts
* Dementia or disability
* Patient without affiliation to the French social security

Primary outcomes:
measure: Percentage of patients with a different form of white matter hyperintensities (WMH)
timeFrame: at the time of specific imaging (between Day 1 to Day 60)
Secondary outcomes:
measure: Frequency of different WMH subtypes in different types of small cerebral vessel disease
timeFrame: at the time of specific imaging (between Day 1 to Day 60)
measure: Frequency of large tract involvement
timeFrame: at the time of specific imaging (between Day 1 to Day 60)
measure: Global cognitive function
timeFrame: at inclusion
measure: Language
timeFrame: at inclusion
measure: Spatial exploration
timeFrame: at inclusion
measure: Spatial memory
timeFrame: at inclusion
measure: Visual memory
timeFrame: at inclusion
measure: Episodic verbal memory
timeFrame: at inclusion
measure: Working memory
timeFrame: at inclusion
measure: Executive function
timeFrame: at inclusion
measure: Attentional Performances status
timeFrame: at inclusion
measure: Depression and Anxiety status
timeFrame: at inclusion
measure: Apathy status
timeFrame: at inclusion
measure: Pulse wave Velocity count
timeFrame: at inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisière
Study officials:
References: