CamSVD: Cambridge 7 Tesla Cerebral Small Vessel Disease Study

• Sponsor: University of Cambridge (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04330222
• Collaborator: Cambridge University Hospitals NHS Foundation Trust (Other), Wolfson Brain Imaging Centre (Other)
• Enrollment: 210
• Location: 1
• Anticipated Duration (Months): 46.1
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Small Vessel Diseases; Cerebral Small Vessel Ischemic Disease; Lacunar Stroke	Diagnostic Test: 7 Tesla Magnetic Resonance Imaging; Other: Brief Memory and Executive Test

Study Design

• Study Type: Observational
• Anticipated Enrollment: 210 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Imaging the Arterial Pathology in Cerebral Small Vessel Disease Using 7 Tesla Magnetic Resonance Imaging
• Actual Study Start Date: Mar 9, 2020
• Anticipated Primary Completion Date: Jan 12, 2024
• Anticipated Study Completion Date: Jan 12, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients with lacunar stroke due to SVD	Diagnostic Test: 7 Tesla Magnetic Resonance Imaging; Diagnostic Imaging; Other: Brief Memory and Executive Test; Cognitive Assessment
Healthy stroke free volunteers	Diagnostic Test: 7 Tesla Magnetic Resonance Imaging; Diagnostic Imaging

Outcome Measures

Primary Outcome Measures

1. Range and pattern of pathology seen in the perforating arteries like presence or absence of focal atheroma and narrowing [March 2020-]

Secondary Outcome Measures

1. Differences in morphology of perforating arteries between SVD patients and healthy volunteers [March 2020-]

2. Correlation of morphology of perforating arteries with cardiovascular risk factors and radiological markers of SVD [March 2020-]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cambridge	Cambridge		United Kingdom	CB2 0QQ

Sponsors and Collaborators

• University of Cambridge
• Cambridge University Hospitals NHS Foundation Trust
• Wolfson Brain Imaging Centre

Investigators

• Principal Investigator: Hugh S Markus, Prof, University of Cambridge Department of Clinical Neurosciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christopher Osuafor, Study Co-ordinator and Co-investigator, University of Cambridge
• ClinicalTrials.gov Identifier: NCT04330222
• Other Study ID Numbers: A095132
• First Posted: Apr 1, 2020
• Last Update Posted: Oct 13, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Christopher Osuafor, Study Co-ordinator and Co-investigator, University of Cambridge: Vascular Cognitive Impairment; Vascular Dementia; 7 Tesla Magnetic Resonance Imagine (7T MRI)
• Additional relevant MeSH terms: Cerebral Small Vessel Diseases; Stroke, Lacunar

Study Results

No Results Posted as of Oct 13, 2021