Cambridge 7 Tesla Cerebral Small Vessel Disease Study

Recruiting

• Conditions: Cerebral Small Vessel Ischemic Disease; Lacunar Stroke; Cerebral Small Vessel Diseases
• Interventions: Diagnostic Test: 7 Tesla Magnetic Resonance Imaging; Other: Brief Memory and Executive Test

• Registration Number: NCT04330222
• Lead Sponsor: University of Cambridge

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-09
• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-04-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21
• Primary Completion: 2024-01-12
• Study Completion: 2024-01-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with lacunar stroke due to SVD	Brief Memory and Executive Test	-
Healthy stroke free volunteers	7 Tesla Magnetic Resonance Imaging	-
Patients with lacunar stroke due to SVD	7 Tesla Magnetic Resonance Imaging	-

Primary Outcome Measures

Name	Time	Method
Range and pattern of pathology seen in the perforating arteries like presence or absence of focal atheroma and narrowing	March 2020-

Secondary Outcome Measures

Name	Time	Method
Correlation of morphology of perforating arteries with cardiovascular risk factors and radiological markers of SVD	March 2020-
Differences in morphology of perforating arteries between SVD patients and healthy volunteers	March 2020-

Trial Locations

Locations (1)

University of Cambridge; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom