Cambridge 7 Tesla Cerebral Small Vessel Disease Study

NCT ID: NCT04330222

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-09

Study Completion Date

2024-01-12

Brief Summary

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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

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Conditions

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Cerebral Small Vessel Diseases Cerebral Small Vessel Ischemic Disease Lacunar Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with lacunar stroke due to SVD

7 Tesla Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

Diagnostic Imaging

Brief Memory and Executive Test

Intervention Type OTHER

Cognitive Assessment

Healthy stroke free volunteers

7 Tesla Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

Diagnostic Imaging

Interventions

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7 Tesla Magnetic Resonance Imaging

Diagnostic Imaging

Intervention Type DIAGNOSTIC_TEST

Brief Memory and Executive Test

Cognitive Assessment

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Wolfson Brain Imaging Centre

UNKNOWN

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role lead

Responsible Party

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Christopher Osuafor

Study Co-ordinator and Co-investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hugh Markus, FMedSci

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge Department of Clinical Neurosciences

Locations

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University of Cambridge

Cambridge, Cambridgeshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Stefania Nannoni, MD

Role: CONTACT

01223 216 509

Christopher Osuafor, MBBS

Role: CONTACT

01223 274 383

Facility Contacts

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Stefania Nannoni, MD

Role: primary

01223 216 509

Laurence Loubiere, PhD

Role: backup

01223 217 695

Other Identifiers

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A095132

Identifier Type: -

Identifier Source: org_study_id

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