Cambridge 7 Tesla Cerebral Small Vessel Disease Study

NCT04330222 | Unknown

• 1 other identifier: A095132
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• Range and pattern of pathology seen in the perforating arteries like presence or absence of focal atheroma and narrowing

  March 2020-

Secondary Outcomes (2)

• Differences in morphology of perforating arteries between SVD patients and healthy volunteers

  March 2020-

• Correlation of morphology of perforating arteries with cardiovascular risk factors and radiological markers of SVD

  March 2020-

Study Arms (2)

Patients with lacunar stroke due to SVD

Diagnostic Test: 7 Tesla Magnetic Resonance Imaging; Other: Brief Memory and Executive Test

Healthy stroke free volunteers

Diagnostic Test: 7 Tesla Magnetic Resonance Imaging

Interventions

7 Tesla Magnetic Resonance Imaging DIAGNOSTIC_TEST

Diagnostic Imaging

Healthy stroke free volunteers; Patients with lacunar stroke due to SVD

Brief Memory and Executive Test OTHER

Cognitive Assessment

Patients with lacunar stroke due to SVD

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lacunar Strokes due to Cerebral Small Vessel Disease

You may qualify if:

• \. Symptomatic lacunar stroke with corresponding lacunar infarct on MRI

You may not qualify if:

• Unable/unwilling to consent;
• Age\<18;
• Stroke aetiology due to cardio-embolism or large vessel disease;
• Lacunar infarcts \>1.5cm;
• Severe stroke (NIHSS score ≥16);
• Evidence of cortical infarct of any size;
• Other major neurological diseases;
• 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;
• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Cambridge

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Stroke, Lacunar; Dementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thrombotic Stroke; Ischemic Stroke; Stroke; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hugh Markus, FMedSci

  University of Cambridge Department of Clinical Neurosciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Nannoni, MD

CONTACT

01223 216 509; sn572@medschl.cam.ac.uk

Christopher Osuafor, MBBS

CONTACT

01223 274 383; co400@cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Co-ordinator and Co-investigator

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: March 9, 2020
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

GB (1)