Cambridge 7 Tesla Cerebral Small Vessel Disease Study

Cerebral Small Vessel Diseases Clinical Trial

— CamSVD  

Official title:

Imaging the Arterial Pathology in Cerebral Small Vessel Disease Using 7 Tesla Magnetic Resonance Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04330222
• Other study ID #: A095132
• Status: Recruiting
• Start date: March 9, 2020
• Est. completion date: January 12, 2024

Study information

• Verified date: September 2022
• Source: University of Cambridge
• Contact: Stefania Nannoni, MD
• Phone: 01223 216 509
• Email: sn572[@]medschl.cam.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: January 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Cerebral Small Vessel Ischemic Disease
• Lacunar Stroke
• Stroke, Lacunar

Intervention

Diagnostic Test:
• 7 Tesla Magnetic Resonance Imaging
Diagnostic Imaging

Other:
• Brief Memory and Executive Test
Cognitive Assessment

Locations

Country	Name	City	State
United Kingdom	University of Cambridge	Cambridge	Cambridgeshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Cambridge	Cambridge University Hospitals NHS Foundation Trust, Wolfson Brain Imaging Centre

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range and pattern of pathology seen in the perforating arteries like presence or absence of focal atheroma and narrowing		March 2020-
Secondary	Differences in morphology of perforating arteries between SVD patients and healthy volunteers		March 2020-
Secondary	Correlation of morphology of perforating arteries with cardiovascular risk factors and radiological markers of SVD		March 2020-