[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635761":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":198,"collaborators":200,"id":219,"slug":220,"hasResults":221,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":221,"sex":227,"minAge":228,"maxAge":12,"enrollmentInfo":229,"targetDuration":12,"studyType":232,"phases":233,"briefSummary":235,"conditions":236,"keywords":247,"overallStatus":100,"whyStopped":12,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":272},{"fullName":5,"class":6},"Maastricht University Medical Center","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Care As Usual (CAU)","NO_INTERVENTION","CAU follows Dutch FMS guidelines, recommending revascularisation for symptomatic patients with ≥50% stenosis and OMT-only for 30-49%. Guidelines suggest risk models like CAR score but lack treatment guidance.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention (IMPROVE) Arm:","EXPERIMENTAL","IMPROVE recommends revascularisation + OMT for patients with ≥10% 3-year ipsilateral stroke risk according to the IMPROVE-score and OMT-only for those with lower than 10% risk.",[18],"Other: IMPROVE Risk Model",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"IMPROVE Risk Model","All patients are screened in routine care for stenosis. The stroke risk is assessed using IMPROVE, incorporating plaque vulnerability (intraplaque haemorrhage (IPH) on MRI), stenosis degree, ischemic event type (ocular vs. cerebral), age and sex. The practitioner and patient discuss treatment options in shared decision making based on this risk score. Patients above the risk threshold (≥10% ipsilateral stroke risk within 3 years) receive a recommendation for revascularisation, those below an advice for OMT-only. The 10% threshold resulted in the largest stroke reduction in the decision analytic study. \\~53% of the patients need an extra MRI. In \\~47% an MRI is unnecessary since, based on the other risk factors, the stroke risk is already high or low and the MRI result does not affect the risk category.",[14],[25,26,27,28,29,30,31,32],"IMPROVE Rule","IMPROVE Decision Rule","IMPROVE Risk Score","IMPROVE Stroke Risk Model","IMPROVE MRI-Based Model","IMPROVE Risk Stratification","IMPROVE Clinical Decision Tool","IMPROVE Risk Assessment",[34],{"name":35,"affiliation":36,"role":37},"M. Eline Kooi, Prof. dr.","Maastricht University","PRINCIPAL_INVESTIGATOR",[39,43],{"name":35,"role":40,"phone":41,"phoneExt":12,"email":42},"CONTACT","+31 43 387 4911","improve.trial@mumc.nl",{"name":44,"role":40,"phone":45,"phoneExt":12,"email":46},"Robin M.M. Pleumeekers, MSc.","+31 43 387 7622","robin.pleumeekers@mumc.nl",[48,69,82,99,114,128,142,156,172,185],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Rijnstate","NOT_YET_RECRUITING","Arnhem","Gelderland","6800 TA","Netherlands","NL",{"type":57,"coordinates":58},"Point",[59,60],5.91111,51.98,{"lat":60,"lon":59},[63,66],{"name":64,"role":40,"phone":12,"phoneExt":12,"email":65},"Sarah Vermeer, Dr.","SVermeer@rijnstate.nl",{"name":67,"role":40,"phone":12,"phoneExt":12,"email":68},"Michelle Simons","MCMSimons@Rijnstate.nl",{"facility":70,"status":50,"city":71,"state":52,"zip":72,"country":54,"countryCode":55,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Radboud UMC","Nijmegen","6525 GA",{"type":57,"coordinates":74},[75,76],5.85278,51.8425,{"lat":76,"lon":75},[79],{"name":80,"role":40,"phone":12,"phoneExt":12,"email":81},"Floris Schreuder, Dr.","floris.schreuder@radboudumc.nl",{"facility":83,"status":50,"city":84,"state":85,"zip":86,"country":54,"countryCode":55,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Zuyderland","Heerlen","Limburg","6419 PC",{"type":57,"coordinates":88},[89,90],5.98154,50.88365,{"lat":90,"lon":89},[93,96],{"name":94,"role":40,"phone":12,"phoneExt":12,"email":95},"Tobien Schreuder, Drs.","t.schreuder@zuyderland.nl",{"name":97,"role":40,"phone":12,"phoneExt":12,"email":98},"Sandra Liedekerken, Drs.","s.liedekerken@zuyderland.nl",{"facility":36,"status":100,"city":101,"state":85,"zip":102,"country":54,"countryCode":55,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"RECRUITING","Maastricht","6229 ER",{"type":57,"coordinates":104},[105,106],5.68889,50.84833,{"lat":106,"lon":105},[109,111],{"name":110,"role":40,"phone":45,"phoneExt":12,"email":46},"Robin Pleumeekers, MSc.",{"name":112,"role":40,"phone":12,"phoneExt":12,"email":113},"Juul Bierens, MSc.","juul.bierens@maastrichtuniversity.nl",{"facility":115,"status":50,"city":116,"state":117,"zip":118,"country":54,"countryCode":55,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Amsterdam UMC","Amsterdam","North Holland","1105 AZ",{"type":57,"coordinates":120},[121,122],4.88969,52.37403,{"lat":122,"lon":121},[125],{"name":126,"role":40,"phone":12,"phoneExt":12,"email":127},"Paul Nederkoorn, Dr.","p.j.nederkoorn@amsterdamumc.nl",{"facility":129,"status":50,"city":130,"state":131,"zip":132,"country":54,"countryCode":55,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Isala","Zwolle","Overijssel","8025 AB",{"type":57,"coordinates":134},[135,136],6.09444,52.5125,{"lat":136,"lon":135},[139],{"name":140,"role":40,"phone":12,"phoneExt":12,"email":141},"Clemens Kersten, Dr.","c.j.b.a.kersten@isala.nl",{"facility":143,"status":50,"city":144,"state":145,"zip":146,"country":54,"countryCode":55,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Albert Schweitzer Ziekenhuis","Dordrecht","South Holland","3300 AK",{"type":57,"coordinates":148},[149,150],4.67361,51.81,{"lat":150,"lon":149},[153],{"name":154,"role":40,"phone":12,"phoneExt":12,"email":155},"Henk Kerkhoff, Dr.","H.Kerkhoff@asz.nl",{"facility":157,"status":50,"city":158,"state":145,"zip":159,"country":54,"countryCode":55,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Erasmus MC","Rotterdam","3000 CA",{"type":57,"coordinates":161},[162,163],4.47917,51.9225,{"lat":163,"lon":162},[166,169],{"name":167,"role":40,"phone":12,"phoneExt":12,"email":168},"Daniel Bos, Dr.","d.bos@erasmusmc.nl",{"name":170,"role":40,"phone":12,"phoneExt":12,"email":171},"Dianne Van Dam-Nolen, Dr.","h.nolen@erasmusmc.nl",{"facility":173,"status":50,"city":174,"state":145,"zip":175,"country":54,"countryCode":55,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Haaglanden MC","The Hague","2501 CK",{"type":57,"coordinates":177},[178,179],4.29861,52.07667,{"lat":179,"lon":178},[182],{"name":183,"role":40,"phone":12,"phoneExt":12,"email":184},"Korné Jellema, Dr.","k.jellema@haaglandenmc.nl",{"facility":186,"status":50,"city":187,"state":187,"zip":188,"country":54,"countryCode":55,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Utrecht UMC","Utrecht","3584 CX",{"type":57,"coordinates":190},[191,192],5.12222,52.09083,{"lat":192,"lon":191},[195],{"name":196,"role":40,"phone":12,"phoneExt":12,"email":197},"Gert Jan De Borst, Prof. dr.","g.j.deborst-2@umcutrecht.nl",{"type":199,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[201,203,204,206,208,209,211,213,215,217],{"name":202,"class":6},"Academisch Ziekenhuis Maastricht",{"name":115,"class":6},{"name":205,"class":6},"UMC Utrecht",{"name":207,"class":6},"Haaglanden Medical Centre",{"name":129,"class":6},{"name":210,"class":6},"Radboud University Medical Center",{"name":212,"class":6},"Zuyderland Medical Centre",{"name":214,"class":6},"Albert Schweitzer Hospital",{"name":216,"class":6},"Rijnstate Hospital",{"name":218,"class":6},"Erasmus Medical Center","100635761","clinical-impact-of-using-improve-to-select-patients-for-carotid-revascularisation-100635761",false,"NCT07556887","Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation","Clinical Impact of the Use of IMPROVE for Selection of Patients for Carotid Revascularisation: a Randomized Controlled Multicentre Non-inferiority Trial in Symptomatic Patients With 30-99% Carotid Stenosis","IMPROVE","Inclusion Criteria:\n\n* Mentally competent\n* 18 years or older\n* Recent (\\\u003C30 days) stroke (modified Rankin scale ≤3) or TIA\n* Ipsilateral 30-99% atheromatous stenosis at the carotid bifurcation assessed using non-invasive imaging according to NASCET criteria\n* Life expectancy \\>5 years\n* Patient and stenosis are suitable for carotid revascularisation\n* Patient is agreeable to randomisation and willing to accept either IMPROVE-based or CAU-based selection method for carotid revascularisation\n\nExclusion Criteria:\n\n* Cardiac source of embolism\n* Carotid stenosis caused by non-atherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy.\n* MRI contra-indications\n* Pregnancy","ALL","18 Years",{"count":230,"type":231},613,"ESTIMATED","INTERVENTIONAL",[234],"NA","Narrowing of the carotid artery due to atherosclerosis with an unstable plaque can cause a stroke. Patients with carotid artery disease who have had a TIA or minor stroke and are at high risk of another stroke are often treated with surgery or stenting to remove the plaque. For lower-risk patients, medication alone is the better option, as surgery also carries risks. A new decision method, based on MRI detection of unstable plaques (IMPROVE), can better assess stroke risk and help determine which patients do or do not need surgery. We are investigating whether this method is at least as effective as the standard approach, which mainly considers the degree of narrowing. We expect that this new method will help reduce strokes and lower healthcare costs.\n\nPatients will be followed for several years to compare which method is better for health and costs.",[237,238,239,240,241,242,243,244,245,246],"Carotid Artery Stenosis Symptomatic","Ischemic Cerebral Infarction","Stroke Ischemic","Atheroscleroses","Stroke (CVA) or TIA","Stroke","Intraplaque Hemorrhage","TIA (Transient Ischemic Attack)","Atherosclerosis Cerebral Infarction","Carotid Arteriosclerosis",[248,249,250,251,252,253,254,255,256,257,258,259,260,261,262],"Carotid Artery Stenosis","Transient Ischemic Attack","Ischemic Stroke","Atherosclerosis","Plaque Rupture","Revascularisation","Carotid Endarterectomy","Carotid Artery Stenting","Magnetic Resonance Imaging","Stroke Risk Prediction","Intraplaque hemorrhage","Clinical Decision Support","Randomized Controlled Mulitcentre Trial","Cost-Effectiveness Analysis","Optimal Medical Therapy","2026-05-12",{"date":265,"type":266},"2026-05-15","ACTUAL",{"date":268,"type":266},"2026-03-31",{"date":270,"type":231},"2031-08-31",{"name":5,"class":6},10]