[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496591":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":25,"responsibleParty":67,"collaborators":70,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":10,"enrollmentInfo":85,"targetDuration":10,"studyType":88,"phases":10,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Cambridge","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"INSVD Cohort",null,"200 patients with cerebral small vessel disease - 100 recruited from Cambridge, UK; 100 recruited from Nijmegen, Netherlands.",[13],{"name":14,"affiliation":5,"role":15},"Hugh S Markus","PRINCIPAL_INVESTIGATOR",[17,21],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},"CONTACT","+44 (0)1223 856661","hsm32@medschl.cam.ac.uk",{"name":22,"role":18,"phone":23,"phoneExt":10,"email":24},"Audrey Low","+44 (0) 1223 216619","al927@medschl.cam.ac.uk",[26,49],{"facility":27,"status":28,"city":29,"state":10,"zip":10,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Radboud University Medical Centre","RECRUITING","Nijmegen","Netherlands","NL",{"type":33,"coordinates":34},"Point",[35,36],5.85278,51.8425,{"lat":36,"lon":35},[39,43,47,48],{"name":40,"role":18,"phone":41,"phoneExt":10,"email":42},"Frank-Erik de Leeuw","+31-24-3613394","frankerik.deleeuw@radboudumc.nl",{"name":44,"role":18,"phone":45,"phoneExt":10,"email":46},"Niels Riksen","+31-34-3618819","Niels.Riksen@radboudumc.nl",{"name":40,"role":15,"phone":10,"phoneExt":10,"email":10},{"name":44,"role":15,"phone":10,"phoneExt":10,"email":10},{"facility":5,"status":28,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Cambridge","Cambridgeshire","CB2 0QQ","United Kingdom","UK",{"type":33,"coordinates":56},[57,58],0.11667,52.2,{"lat":58,"lon":57},[61,63,64,65],{"name":14,"role":18,"phone":62,"phoneExt":10,"email":20},"+44 (0) 1223 856661",{"name":22,"role":18,"phone":23,"phoneExt":10,"email":24},{"name":14,"role":15,"phone":10,"phoneExt":10,"email":10},{"name":66,"role":15,"phone":10,"phoneExt":10,"email":10},"Ziad Mallat",{"type":15,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Hugh Markus","Principal Investigator",[71,73],{"name":72,"class":6},"Radboud University Medical Center",{"name":74,"class":75},"Wolfson Brain Imaging Centre","UNKNOWN","100496591","inflammation-and-small-vessel-disease-study-100496591",false,"NCT05746221","INflammation and Small Vessel Disease Study","INSVD","Inclusion Criteria:\n\n* Have given written informed consent to participate\n* Be aged 40 years and over\n* Have symptomatic cerebral small vessel disease (SVD) defined as:\n* Clinical lacunar stroke syndrome with lacunar infarct, as defined by the Standards for Reporting Vascular Changes on Neuroimaging (STRIVE) criteria\n* And\u002FOR Symptoms of cognitive impairment due to SVD with lacunar infarct on MRI\n* And\u002FOR Gait apraxia\u002Fmotor impairment presumed due to SVD with lacunar infarct on MRI\n\nExclusion Criteria:\n\n* Unable\u002Funwilling to consent including lack of capacity to consent\n* Contraindications to taking part in MRI study as assessed by the local MRI safety questionnaire, e.g., pacemaker\n* Vaccination or infection with fever in preceding month\n* Any stroke cause other than SVD including:\n* Cardioembolic source\n* Carotid or vertebral stenosis \\> 50% measured on NASCET (North American Symptomatic Carotid Endarterectomy Trial) criteria\n* Myocardial infarction in past year\n* Auto-immune\u002Fauto-inflammatory disease\n* Use of immunomodulating drugs\n* Estimated glomerular filtration rate (eGFR) =\\\u003C59 ml\u002Fmin\u002F1.73m2 within past 3 months for Cambridge, and eGFR =\\\u003C29 ml\u002Fmin\u002F1.73m2 within past 3 months for Nijmegen, in line with local guidelines. Estimated GFR will be calculated using the Modification of Diet in Renal Disease (MDRD) equation: 186 x (Creatinine \u002F 88.4)-1.154 x (Age)- 0.203 x (0.742 if female) x (1.210 if black). Creatinine will be checked within 3 months of the MRI, and if this has not been done as part of clinical care it will be performed as a research procedure.\n* Another diagnosed chronic neurological condition (e.g. Alzheimer's, Parkinson's disease, motor neurone disease, multiple sclerosis).\n* Limited life expectancy due to another illness or chronic condition making the 2-year follow-up difficult (e.g. widespread malignancy).\n* Known monogenic cause of small vessel disease (e.g. CADASIL - Cerebral Autosomal Dominant Arteriopathy with Sub-cortical Infarcts and Leukoencephalopathy)","ALL","40 Years",{"count":86,"type":87},200,"ESTIMATED","OBSERVATIONAL","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.",[91,92,93],"Cerebral Small Vessel Diseases","Inflammation","Stroke",[95,92,93,96,97,98,99,100],"Cerebral small vessel disease","Cerebrovascular disease","Lacunar stroke","White matter disease","Cognitive impairment","Blood brain barrier","2023-02-17",{"date":103,"type":104},"2023-02-27","ACTUAL",{"date":106,"type":104},"2022-08-10",{"date":108,"type":87},"2026-07-31",{"name":5,"class":6},2]