Clinical trial NCT04330222: Cambridge 7 Tesla Cerebral Small Vessel Disease Study
Official title: Imaging the Arterial Pathology in Cerebral Small Vessel Disease Using 7 Tesla Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Small Vessel Diseases
Cerebral Small Vessel Ischemic Disease
Lacunar Stroke
Keywords: Vascular Cognitive Impairment
Vascular Dementia
7 Tesla Magnetic Resonance Imagine (7T MRI)
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
name: Wolfson Brain Imaging Centre
First posted: 2020-04-01
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lacunar Strokes due to Cerebral Small Vessel Disease

Brief summary: CamSVD is jointly sponsored by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust.

We aim to explore and understand the underlying arterial pathology in Cerebral Small Vessel Disease (SVD) using ultra-high-field 7 Tesla MRI. We will optimise 7T Time-of-Flight MR angiography, blood suppressed MR sequence and phase-contrast (PC) MR angiography for visualization of perforating lenticulostriate arteries. This optimised sequences will be used to determine the range of arterial pathologies seen in individuals presenting with lacunar strokes. The pathologies of the perforating lenticulostriate arteries will be correlated with conventional clinical risk factors, cognition and radiological markers of SVD.


Eligibility criteria: Inclusion Criteria:

1. Symptomatic lacunar stroke with corresponding lacunar infarct on MRI

Exclusion Criteria:

1. Unable/unwilling to consent;
2. Age\<18;
3. Stroke aetiology due to cardio-embolism or large vessel disease;
4. Lacunar infarcts \>1.5cm;
5. Severe stroke (NIHSS score ≥16);
6. Evidence of cortical infarct of any size;
7. Other major neurological diseases;
8. Severe systemic diseases such as heart failure, liver failure and kidney failure or any illness in the judgement of the investigator that could affect participation in the study;
9. MRI contraindications e.g. metal objects in or on the body, claustrophobia, pregnancy, known allergy to gadolinium containing contrast agent, impaired renal function with estimated glomerular filtration rate (eGFR) \<59ml/min/1.73m2.

Primary outcomes:
measure: Range and pattern of pathology seen in the perforating arteries like presence or absence of focal atheroma and narrowing
timeFrame: March 2020-
Secondary outcomes:
measure: Differences in morphology of perforating arteries between SVD patients and healthy volunteers
timeFrame: March 2020-
measure: Correlation of morphology of perforating arteries with cardiovascular risk factors and radiological markers of SVD
timeFrame: March 2020-
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: University of Cambridge
state: Cambridgeshire
Study officials:
affiliation: University of Cambridge Department of Clinical Neurosciences
name: Hugh Markus, FMedSci
role: PRINCIPAL_INVESTIGATOR
References: