Actively Recruiting

Age: 40Years +
All Genders
NCT05746221

INflammation and Small Vessel Disease Study

Led by University of Cambridge · Updated on 2023-02-27

200

Participants Needed

2

Research Sites

207 weeks

Total Duration

On this page

Sponsors

U

University of Cambridge

Lead Sponsor

R

Radboud University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

A prospective observational cohort study in patients with cerebral small vessel disease deterring whether changes in systemic inflammation predict brain white matter damage measured using MRI and cognitive decline. This is a study funded by a joint BHF-Dutch Heart Foundation research grant and will be conducted in both Cambridge UK and Nijmegen Netherlands with 100 of the 200 total participants recruited at each site, and data from both sites analysed together.

CONDITIONS

Official Title

INflammation and Small Vessel Disease Study

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have given written informed consent to participate
  • Be aged 40 years and over
  • Have symptomatic cerebral small vessel disease (SVD) defined as clinical lacunar stroke syndrome with lacunar infarct per STRIVE criteria
  • And/or symptoms of cognitive impairment due to SVD with lacunar infarct on MRI
  • And/or gait apraxia or motor impairment presumed due to SVD with lacunar infarct on MRI
Not Eligible

You will not qualify if you...

  • Unable or unwilling to consent including lack of capacity to consent
  • Contraindications to MRI, such as having a pacemaker
  • Recent vaccination or infection with fever in the past month
  • Any stroke cause other than SVD, including cardioembolic source or carotid/vertebral stenosis over 50% per NASCET criteria
  • Myocardial infarction in the past year
  • Autoimmune or auto-inflammatory disease
  • Use of immunomodulating drugs
  • Reduced kidney function with eGFR \u2264 59 ml/min/1.73m2 in Cambridge or \u2264 29 ml/min/1.73m2 in Nijmegen within past 3 months
  • Another diagnosed chronic neurological condition (e.g., Alzheimer's, Parkinson's, motor neurone disease, multiple sclerosis)
  • Limited life expectancy due to another illness making 2-year follow-up difficult
  • Known monogenic cause of small vessel disease (e.g., CADASIL)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Radboud University Medical Centre

Nijmegen, Netherlands

Actively Recruiting

2

University of Cambridge

Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

Actively Recruiting

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Research Team

H

Hugh S Markus

CONTACT

A

Audrey Low

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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