Cambridge 7 Tesla Cerebral Small Vessel Disease Study (CamSVD)

September 19, 2022 updated by: Christopher Osuafor, University of Cambridge

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Christopher Osuafor, MBBS
  • Phone Number: 01223 274 383
  • Email: co400@cam.ac.uk

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lacunar Strokes due to Cerebral Small Vessel Disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Range and pattern of pathology seen in the perforating arteries like presence or absence of focal atheroma and narrowing
Time Frame: March 2020-
March 2020-

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in morphology of perforating arteries between SVD patients and healthy volunteers
Time Frame: March 2020-
March 2020-
Correlation of morphology of perforating arteries with cardiovascular risk factors and radiological markers of SVD
Time Frame: March 2020-
March 2020-

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cambridge

Collaborators

Cambridge University Hospitals NHS Foundation Trust
Wolfson Brain Imaging Centre

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2020

Primary Completion (Anticipated)

January 12, 2024

Study Completion (Anticipated)

January 12, 2024

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A095132

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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