Clinical trial NCT05200377: Magnetic Resonance Imaging in Cerebral Small Vessel Disease
Official title: Magnetic Resonance Imaging in Cerebral Small Vessel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Small Vessel Diseases
MRI
Keywords: Cerebral small vessel diseases
Cognitive impairments
Lesion burden
MRI
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinically or radiologically evidenced cerebral small vessel disease.

Brief summary: Cerebral small vessel disease (cSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of cSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) may represent as a sensitive and robust tool to detect early changes in brain subtle structures and functions. The study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced MRI technologies in early diagnosis and management of cSVD.

Detailed description: Cerebral small vessel disease (cSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of cSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) is sensitive to change in white matter structure and subtle vascular function alternation which correlates with cognition impairments in cSVD. MRI manifestation may also represent as useful surrogate marker. Development of advanced MRI technologies promotes their invaluable application in brain and vascular qualitative and quantitative assessment. The study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced MRI technologies in early diagnosis and management of cSVD.

Eligibility criteria: Inclusion Criteria:

* Clinical evidence of cerebral small vessel disease or MRI evidence of lacunar infarcts and white matter hyperintensity
* No disability (modified Rankin's scale \< 2)
* No dementia (MMSE \> 24 and absence of dependence in daily activities)
* Able and willing to consent

Exclusion Criteria:

* Contraindications to MRI
* Standard MRI of bad quality due to movement artefacts
* Pregnant
* Unable to tolerate MRI

Primary outcomes:
measure: Progression in total cerebral small vessel disease burden
timeFrame: 1 year
Secondary outcomes:
measure: Progression in congnitive impairments
timeFrame: 1 years
measure: Recurrent ischemic events
timeFrame: 1 year
measure: Modified Rankin Scale
timeFrame: 90 days and 1 year after qualifying event
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Xin Lou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wardlaw JM, Smith C, Dichgans M. Small vessel disease: mechanisms and clinical implications. Lancet Neurol. 2019 Jul;18(7):684-696. doi: 10.1016/S1474-4422(19)30079-1. Epub 2019 May 13.