White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI (SV7)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Cerebral Small Vessel Diseases

Treatments: Other: Experimental Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04298866

APHP180445

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Experimental arm

Other group

Treatment:

Other: Experimental Arm