[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462834":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":65,"centralContacts":77,"locations":84,"responsibleParty":113,"collaborators":32,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":32,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":136,"overallStatus":87,"whyStopped":32,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Minimal cSVD patient group","ACTIVE_COMPARATOR","little or no white matter hyperintensities",[13,14,15,16,17,18,19,20,21],"Procedure: Retinal Imaging","Genetic: Blood sample","Procedure: Evaluation of cardiovascular risks","Procedure: Brain imaging (MRI)","Other: Cognitive Tests","Other: Geriatric Depression Scale (GDS)","Other: Instrumental Activities of Daily Living (IADL)","Diagnostic Test: Unipodal standing test","Other: Walking speed measurement",{"label":23,"type":10,"description":24,"interventionNames":25},"Extensive cSVD patient group","moderate to severe white matter hyperintensities",[13,14,15,16,17,18,19,20,21],[27,33,38,42,46,50,54,57,61],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Retinal Imaging","Auto-Refractometry \u002F Adaptative Optics (OA) \u002F Swept Source Optical Coherence Tomography (SS-OCT-A) \u002F Globe Axial length measurements \u002F Color Retinophotography of the retina.",[23,9],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"GENETIC","Blood sample","Analyses of molecular biomarkers including",[23,9],{"type":28,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"Evaluation of cardiovascular risks","Measurement of blood pressure and arterial stiffness",[23,9],{"type":28,"name":43,"description":44,"armGroupLabels":45,"otherNames":32},"Brain imaging (MRI)","3DT1 \u002F 3DFLAIR \u002F T2GRE \u002F DTI 15 directions (and B0MAP)",[23,9],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":32},"Cognitive Tests","Mini Mental State Examination (MMSE) \u002F Montreal Cognitive Assessment (MoCA) \u002F 16 items Free and Cued Recall (RL\u002FRI 16 items) \u002F Trail Making Test A et B (TMT A et B) \u002F Frontal Assessment Battery (FAB) \u002F Phonemic (letter P) and semantic (animals) verbal fluency tests \u002F Digit Symbol Substitution Test (DSST)",[23,9],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":32},"Geriatric Depression Scale (GDS)","15 items",[23,9],{"type":6,"name":55,"description":55,"armGroupLabels":56,"otherNames":32},"Instrumental Activities of Daily Living (IADL)",[23,9],{"type":58,"name":59,"description":59,"armGroupLabels":60,"otherNames":32},"DIAGNOSTIC_TEST","Unipodal standing test",[23,9],{"type":6,"name":62,"description":63,"armGroupLabels":64,"otherNames":32},"Walking speed measurement","over 5 meters",[23,9],[66,70,74],{"name":67,"affiliation":68,"role":69},"Olivier HANON, Pr","Assistance Publique - Hôpitaux de Paris","PRINCIPAL_INVESTIGATOR",{"name":71,"affiliation":72,"role":73},"Marc JOLIOT, Dr","Unité CNRS UMR5296, Groupe d'Imagerie","STUDY_CHAIR",{"name":75,"affiliation":76,"role":73},"Cécile DELCOURT, Dr","Centre INSERM U1219 Bordeaux Population Health",[78],{"name":79,"role":80,"phone":81,"phoneExt":82,"email":83},"Stéphanie DEBETTE, Pr","CONTACT","5.57.57.16.59","+33","stephanie.debette@u-bordeaux.fr",[85,101],{"facility":86,"status":87,"city":88,"state":32,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Bordeaux Hospital","RECRUITING","Bordeaux","33000","France","FR",{"type":93,"coordinates":94},"Point",[95,96],-0.58046,44.84124,{"lat":96,"lon":95},[99],{"name":100,"role":80,"phone":32,"phoneExt":32,"email":32},"DEBETTE Stéphanie, Pr",{"facility":102,"status":87,"city":103,"state":32,"zip":104,"country":90,"countryCode":91,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Broca Hospital","Paris","75014",{"type":93,"coordinates":106},[107,108],2.3488,48.85341,{"lat":108,"lon":107},[111],{"name":112,"role":80,"phone":32,"phoneExt":32,"email":32},"HANON Olivier, Pr",{"type":114,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100462834","stopping-cognitive-decline-and-dementia-by-fighting-covert-cerebral-small-vessel-disease-100462834",false,"NCT05306834","Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease","SHIVA","Inclusion Criteria:\n\nFor the extensive cSVD patient group\n\n1. For the extensive cSVD patient group included in the LEOPOLD trial:\n\n   * Patients aged 60 to 88 years,\n   * Patients included in the LEOPOLD trial and having performed their brain MRI on SIEMENS PRISMA machine\n   * Being affiliated or beneficiary of the French national health insurance (\"sécurité sociale\"),\n   * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research study).\n2. For the extensive cSVD patient group not included in the LEOPOLD trial:\n\n   * Patients aged 60 to 88 years,\n   * Patients with a cognitive complaint MMSE ≥ 20 performed in the 6 months before inclusion, associated or not with impaired cognitive tests and\u002For diaognosis of incipient dementia without pronounced cognitive deterioration,\n   * Patients with a socio-educational level ≥ 3,\n   * Patients with a moderate to high grade of hypersignals on an MRI OR on an CT scan performed prior inclusion (grades C and D of the modified Scheltens scale or grade 2\u002F3 Fazekas),\n   * Arterial hypertension defined by a Systolic Blood Pressure (SBP) and \u002F or Diastolic Blood Pressure (DBP) ≥ 140\u002F90 mmHg (according to the definition of the national health authority \\[HAS\\]), treated or not, confirmed within the previous 12 months or at the latest on the day of inclusion.\n   * Being affiliated or beneficiary of the French national health insurance (\"sécurité sociale\"),\n   * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research study)\n\nFor the minimal cSVD patient group:\n\n* Patients aged 60 to 88 years,\n* Patients with a cognitive complaint (MMSE ≥ 20 performed at the SHIVA inclusion visit or in the 6 monts prior the visit) associated or not with impaired cognitive tests and\u002For diagnosis of incipient dementia without pronounced cognitive deterioration,\n* Patients with little or no white matter hypertensities on brain MRI (grades 0 or 1 on the Fazekas scale); without lacunes or microbleeds,\n* Arterial hypertension defined by a Systolic Blood Pressure (SBP) and \u002F or Diastolic Blood Pressure (DBP) ≥ 140\u002F90 mmHg (according to the definition of the national health authority \\[HAS\\]), treated or not, confirmed within the previous 12 months or at the latest on the day of inclusion. Blood pressure values for this inclusion criterion can be objectified by several self-measurements performed by the patient at home for 3 days in a sitting or lying position (3 measurements on sitting or lying position and 3 measurements in standing position).\n* Being affiliated or beneficiary of the French national health insurance (\"sécurité sociale\"),\n* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research study\n\nExclusion Criteria:\n\nFor Extensive cSVD patient group :\n\n1. For the extensive cSVD patient group also included in the LEOPOLD trial:\n\n   * patients with severe myopia greater than -6 dioptres\n   * partients with known allergy to Tropicamide (Mydriaticum®)\n   * patients with an extensive cataract\n   * patients with ptosis\n2. For the extensive cSVD patient group not included in the LEOPOLD trial:\n\n   * Orthostatic hypotension defined by a decrease of 20 mmHg in SBP and \u002F or 10 mmHg in DBP in a standing position at 3 minutes sought in the previous 3 months or on the day of inclusion,\n   * Very severe renal impairment (creatinine clearance less than 15 ml \u002F min) on a blood test dating back less than one year,\n   * Secondary hypertension: renovascular hypertension, primary hyperaldosteronism, pheochromocytoma...\n   * Contraindication to MRI (presence of a ferromagnetic foreign body, in particular certain intracranial clips, certain heart valves, an intraocular foreign body, metal prosthesis, subject carrying a pacemaker, subject carrying prosthetic heart valves incompatible with MRI. ventricular shunt, claustrophobia),\n   * Associated severe diseases, with a life expectancy of less than 3 months,\n   * Physical problems likely to interfere with the feasibility of the tests (sight, hearing, etc.),\n   * Existence of dementia of which the etiology is distinct from Alzheimer's disease, vascular or mixed dementia\n   * Persons under tutorship or curatorship,\n   * Patients with loss of autonomy living in EHPAD (nursing home)\n   * patients with severe myopia greater than -6 dioptres\n   * participants with known allergy to Tropicamide (Mydriaticum®)\n   * patients with an extensive cataract\n   * patients with ptosis\n\nFor the minimal cSVD patient group:\n\n* Orthostatic hypotension defined by a decrease of 20 mmHg in SBP and \u002F or 10 mmHg in DBP in a standing position at 3 minutes sought in the previous 3 months or on the day of inclusion,\n* Very severe renal impairment (creatinine clearance less than 15 ml \u002F min) on a blood test dating back less than one year,\n* Secondary hypertension: renovascular hypertension, primary hyperaldosteronism, pheochromocytoma...\n* Contraindication to MRI (presence of a ferromagnetic foreign body, in particular certain intracranial clips, certain heart valves, an intraocular foreign body, metal prosthesis, subject carrying a pacemaker, subject carrying prosthetic heart valves incompatible with MRI. ventricular shunt, claustrophobia),\n* Associated severe diseases, with a life expectancy of less than 3 months,\n* Physical problems likely to interfere with the feasibility of the tests (sight, hearing, etc.),\n* Existence of dementia of which the etiology is distinct from Alzheimer's disease, vascular or mixed dementia\n* Persons under tutorship or curatorship,\n* Patients with loss of autonomy living in EHPAD (nursing home)\n* Patients with severe myopia greater than -6 dioptries\n* Patients with known allergy to Tropicamide (Mydriaticum®)\n* Patients with an extensive cataract\n* Patients with ptosis","ALL","60 Years","88 Years",{"count":126,"type":127},400,"ESTIMATED","INTERVENTIONAL",[130],"NA","Cerebral small Vessel Disease (cSVD), characterized by an alteration of the structure and function of small penetrating brain arteries, is highly prevalent in older persons from the general population and represents a leading cause of stroke and a major contributor to cognitive decline and dementia risk. In France \\>4 million persons aged 60+ are estimated to have moderate to extensive covert cSVD (ccSVD), i.e. features of SVD on brain imaging without a history of clinical stroke. Better detection and management of covert cSVD would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. However, there are no specific mechanistic treatments for cSVD and hardly any recommendations worldwide on how to prevent and treat cSVD and related cognitive impairment. The aim of the present study, through the identification of novel cutting-edge multimodal biomarkers, is to develop innovative diagnostic and risk prediction tools for cSVD and its complications and to contribute to accelerating the discovery of novel drug targets and therapeutics strategies for cSVD.",[133,134,135],"Cerebral Small Vessel Diseases","Stroke","Dementia",[137,135,134,138,139,140,141,142,143,144,145,146,147,148],"Cognitive decline","Small vessel disease","Healthy brain aging","Brain imaging","Adaptive optics","Optical coherence tomography angiography","Prevention","Risk prediction","Genomic","Multiomics","Proteomics","Metabolomics","2024-01-25",{"date":151,"type":152},"2024-01-26","ACTUAL",{"date":154,"type":152},"2022-11-10",{"date":156,"type":127},"2027-11",{"name":5,"class":6},2]