[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643819":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":66,"collaborators":68,"id":75,"slug":37,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":37,"enrollmentInfo":84,"targetDuration":37,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":37,"overallStatus":95,"whyStopped":37,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",[8,15,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Volunteers","EXPERIMENTAL","Adults without known hypertension, type 2 diabetes, or chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.",[13,14],"Device: HEMI device","Device: SPG-NINOX device",{"label":16,"type":10,"description":17,"interventionNames":18},"Hypertension Without Chronic Kidney Disease","Adults with hypertension and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Type 2 Diabetes Mellitus Without Chronic Kidney Disease","Adults with type 2 diabetes mellitus and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Moderate Chronic Kidney Disease","Adults with moderate chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Severe Chronic Kidney Disease","Adults with severe chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.",[13,14],[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DEVICE","HEMI device","Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.",[9,16,24,28,20],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"SPG-NINOX device","Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.",[9,16,24,28,20],[43],{"name":44,"role":45,"phone":46,"phoneExt":37,"email":47},"Rosa Maria BRUNO, Professor","CONTACT","+33 1 53 98 79 67","rosa-maria.bruno@inserm.fr",[49],{"facility":50,"status":37,"city":51,"state":37,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"INSERM U970, Equipe 7, 56 rue Leblanc","Paris","75015","France","FR",{"type":56,"coordinates":57},"Point",[58,59],2.3488,48.85341,{"lat":59,"lon":58},[62,64],{"name":63,"role":45,"phone":46,"phoneExt":37,"email":47},"Rosa Maria BRUNO, Pr",{"name":63,"role":65,"phone":37,"phoneExt":37,"email":37},"PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[69,72],{"name":70,"class":71},"University of Turku","OTHER",{"name":73,"class":74},"Imec","INDUSTRY","100643819",false,"NCT07604922","Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease","STIMULUS-CKD","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n\n  * Adults aged over 18 years, of both sexes\n  * Patients eligible for or affiliated with a social security scheme\n  * Patients who have provided written informed consent to participate in the study\n\nCommon Exclusion Criteria:\n\n* Inability to give informed consent\n* Persons under legal protection (guardianship, trusteeship, or court protection)\n* Language barrier or psychological refusal to read the information\n* Medical conditions with a life expectancy \\\u003C 1 year according to clinical judgment\n* Ongoing participation restriction due to another clinical research study\n* Pregnant women (due to physiological hemodynamic changes in blood pressure and arterial stiffness during pregnancy)\n* Cardiac arrhythmias: current atrial fibrillation or high-degree atrioventricular block\n\nExclusion Criteria:\n\n* Hypertension Group\n\n  * Inclusion: Prior diagnosis of arterial hypertension\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n\n    * CKD with GFR \\\u003C60 mL\u002Fmin\n    * ACR \\> 30 mg\u002Fmmol\n    * Type 2 diabetes Type 2 Diabetes Group\n  * Inclusion:\n  * Prior diagnosis of type 2 diabetes\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n\n    * CKD with GFR \\\u003C 60 mL\u002Fmin\n    * ACR \\> 30 mg\u002Fmmol Moderate CKD Group\n  * Inclusion:\n  * Moderate CKD (eGFR between 30 and 60 mL\u002Fmin) (CKD-EPI)\n  * Patients scheduled for arterial stiffness assessment as part of routine care\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n  * No specific exclusion criteria beyond common exclusions Severe CKD Group\n  * Inclusion:\n\n    * Severe CKD (GFR \\\u003C 30 mL\u002Fmin for ≥ 2 months)\n    * Patients scheduled for arterial stiffness assessment as part of routine care\n    * Stable cardiovascular treatment the previous 1 month\n  * Exclusion: No specific exclusion criteria beyond common exclusions20 \u002F 48 C25-07\\_Protocole\\_ V1.0\\_01.12.2025 Healthy Volunteers Group\n  * Inclusion: No documented chronic disease\n  * Exclusion:\n\n    * Moderate or severe CKD (GFR \\\u003C 60 mL\u002Fmin) (CKD-EPI)\n    * Hypertension\n    * Type 2 diabetes\n    * Stable cardiovascular treatment in the previous 1 month",true,"ALL","18 Years",{"count":85,"type":86},165,"ESTIMATED","INTERVENTIONAL",[89],"NA","This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD. The primary objective is to compare baseline small vessel pressure measured with the HEMI (Multi-spectral optical system for microcirculation hemodynamics) device across groups in order to identify microvascular alterations associated with cardiometabolic and renal disease. Secondary objectives include assessment of microvascular responses after post-ischemic hyperemia, evaluation of SPG-derived (Speckle plethysmography) small vessel flow and volume parameters, comparison with reference vascular measurements (including SphygmoCor and ultra-high frequency ultrasound), and evaluation of feasibility, acceptability, and measurement reproducibility. Participation is non-randomized, based on participants' pre-existing clinical condition, and study procedures are non-invasive with an expected visit duration of approximately 60 minutes.",[92,93,94],"Chronic Kidney Disease","Hypertension (HTN)","Type 2 Diabetes Mellitus (T2DM)","NOT_YET_RECRUITING","2026-06-04",{"date":98,"type":99},"2026-06-08","ACTUAL",{"date":101,"type":86},"2026-06-15",{"date":103,"type":86},"2028-09-15",{"name":5,"class":6},1]