Cerebral Small Vessel DiseasesCamSVDNCT04330222
Cambridge 7 Tesla Cerebral Small Vessel Disease Study
An observational study of Cerebral Small Vessel Diseases and Cerebral Small Vessel Ischemic Disease, run by University of Cambridge at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Small Vessel Diseases, Cerebral Small Vessel Ischemic Disease, Lacunar Stroke
- What is being tested?
- 7 Tesla Magnetic Resonance Imaging and Brief Memory and Executive Test
- How many people
- 210 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Mar 2020to 12 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lacunar Strokes due to Cerebral Small Vessel Disease
Who may be able to join
- 1. Symptomatic lacunar stroke with corresponding lacunar infarct on MRI
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Cambridge
Cambridge, Cambridgeshire, CB2 0QQ
Stefania Nannoni, MD, 01223 216 509, sn572@medschl.cam.ac.uk
Laurence Loubiere, PhD, 01223 217 695, lhl31@medschl.cam.ac.uk
About this study
Official title: 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.
- Being tested
- 7 Tesla Magnetic Resonance Imaging, Brief Memory and Executive Test
- Keywords
- Vascular Cognitive Impairment, Vascular Dementia, 7 Tesla Magnetic Resonance Imagine (7T MRI)
- Medical subject headings
- Cerebral Small Vessel Diseases, Stroke, Lacunar, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 Tesla Magnetic Resonance ImagingDiagnostic test
Diagnostic Imaging
Brief Memory and Executive TestOther
Cognitive Assessment
| Study group | Role | What they receive |
|---|---|---|
| Patients with lacunar stroke due to SVD | Not described Receives: Diagnostic Test: 7 Tesla Magnetic Resonance Imaging; Other: Brief Memory and Executive Test | |
| Healthy stroke free volunteers | Not described Receives: Diagnostic Test: 7 Tesla Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range and pattern of pathology seen in the perforating arteries like presence or absence of focal atheroma and narrowing
Measured: March 2020-
Secondary outcomes (2)
Differences in morphology of perforating arteries between SVD patients and healthy volunteers
Measured: March 2020-
Correlation of morphology of perforating arteries with cardiovascular risk factors and radiological markers of SVD
Measured: March 2020-
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start9 Mar 2020
- Primary completion12 Jan 2024 (estimated)
- Study completion12 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Wolfson Brain Imaging Centre
- Responsible party
- Principal investigator, Christopher Osuafor, University of Cambridge
- Investigators
- Hugh Markus, FMedSci, Principal investigator, University of Cambridge Department of Clinical Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330222
- Sponsor's protocol ID
- A095132
- Acronym
- CamSVD
- Status last verified
- Sep 2022
- First submitted
- 30 Mar 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging the Arterial Pathology in Cerebral Small Vessel Disease Using 7 Tesla Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04330222
- Acronym / sponsor ID
- CamSVD / A095132
- Keywords
- Vascular Cognitive Impairment, Vascular Dementia, 7 Tesla Magnetic Resonance Imagine (7T MRI)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Wolfson Brain Imaging Centre
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 12 Jan 2024 (estimated)
- Study completion
- 12 Jan 2024 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lacunar Strokes due to Cerebral Small Vessel Disease
Key inclusion criteria (1 listed)
- 1. Symptomatic lacunar stroke with corresponding lacunar infarct on MRI
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 Tesla Magnetic Resonance ImagingDiagnostic Imaging | Diagnostic test | Healthy stroke free volunteers, Patients with lacunar stroke due to SVD |
| Brief Memory and Executive TestCognitive Assessment | Other | Patients with lacunar stroke due to SVD |
Primary outcome
Range and pattern of pathology seen in the perforating arteries like presence or absence of focal atheroma and narrowing
Time frame: March 2020-
2 secondary outcomes
Differences in morphology of perforating arteries between SVD patients and healthy volunteers
Time frame: March 2020-
Correlation of morphology of perforating arteries with cardiovascular risk factors and radiological markers of SVD
Time frame: March 2020-
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh Markus, FMedSci principal investigator
University of Cambridge Department of Clinical Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessel Diseases and Cerebral Small Vessel Ischemic Disease, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefania Nannoni, MD (01223 216 509, sn572@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range and pattern of pathology seen in the perforating arteries like presence or absence of focal atheroma and narrowing (time frame: March 2020-). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.