[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623979":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":46,"locations":54,"responsibleParty":119,"collaborators":121,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":143,"sex":149,"minAge":150,"maxAge":20,"enrollmentInfo":151,"targetDuration":20,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":20,"overallStatus":70,"whyStopped":20,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Aventyn, Inc.","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","PLACEBO_COMPARATOR","All qualified cardio kidney metabolic (CKM) patients including Congestive Heart Failure (CHF) subjects in Intervention Arm",[13,14,15],"Other: CHAPERONE AI","Device: CKMiq AI","Other: Quality of Life",{"label":17,"type":18,"description":19,"interventionNames":20},"Control","NO_INTERVENTION","All qualified cardio kidney metabolic patients including CHF subjects in control arm",null,[22,27,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":20},"OTHER","CHAPERONE AI","The primary objective of this study is to evaluate the efficacy of treatment strategy on the impact of an intervention that is AI, Machine Learning (ML) based using Chatbot and Copilot with algorithm based intervention in CKM subjects in reducing progression of CKM diseases. This will be based on an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment. Improvement of patient outcomes will be measured by reduction of composite of Kidney failure\u002Fprogression of kidney disease, Heart failure, acute myocardial infarction (AMI) events and diabetes complications and hospitalization as well as all-cause mortality through 30 days, 90 days and 180 days in CKM patients",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":20},"DEVICE","CKMiq AI","To evaluate the effect of treatment in: reducing readmission's from cardiovascular causes using an algorithm-based intervention of LIFE ESSENTIAL 8 biomarkers obtained from info graphic resources provided by American Heart Association. Improving subject self-assessed risk score overall well-being as measured by self-assessed Copilot Likert scale at 30 days, 90 days and 180 days from hospitalization. Increasing the number of days alive and outside the hospital from hospitalization through day 30, 90 and Day 180. Reducing the composite of cardiovascular re-hospitalization and cardiovascular mortality from hospitalization through 30, 90 and 180 days. New York Heart Association (NYHA) Class and Kansas City Cardiomyopathy Questionnaire (KCCQ) will be captured.",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Quality of Life","Secondary and tertiary objectives of this study are to evaluate the effect of CHAPERONE intervention in: Improving LIFE ESSENTIAL-8 Score and Health Related Quality of Life (HRQOL) measured with the 12-item Short Form (SF-12) survey, which reflects general health status and leads to 2 scores",[9],[37],"CKM QOL",[39,42],{"name":40,"affiliation":5,"role":41},"Kris Vijay Study Chair, MD","STUDY_CHAIR",{"name":43,"affiliation":44,"role":45},"Zaki Lababidi PI, MD","Gilbert Cardiology","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":20,"email":51},"Navin Govind Steering Committtee, MS","CONTACT","2317942328","info@aventyn.com",{"name":53,"role":49,"phone":50,"phoneExt":20,"email":20},"Aditya Vijay, MS",[55,69,81,95,104],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":20},"Fountains Family Care","COMPLETED","Chandler","Arizona","85248","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-111.84125,33.30616,{"lat":67,"lon":66},{"facility":44,"status":70,"city":71,"state":59,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"RECRUITING","Gilbert","85297",{"type":64,"coordinates":74},[75,76],-111.78903,33.35283,{"lat":76,"lon":75},[79],{"name":80,"role":49,"phone":20,"phoneExt":20,"email":20},"Sharolyn McClurg Coordinator, MSN, CNP",{"facility":82,"status":70,"city":83,"state":59,"zip":84,"country":61,"countryCode":62,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Arizona Heart Foundation","Phoenix","85014",{"type":64,"coordinates":86},[87,88],-112.07404,33.44838,{"lat":88,"lon":87},[91,93],{"name":92,"role":49,"phone":20,"phoneExt":20,"email":20},"Eileen Spengler, RCS, FASE",{"name":92,"role":94,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"facility":96,"status":57,"city":97,"state":59,"zip":98,"country":61,"countryCode":62,"cosmosGeoPoint":99,"geoPoint":103,"contacts":20},"East Valley Diabetes","San Tan Valley","85143",{"type":64,"coordinates":100},[101,102],-111.528,33.1911,{"lat":102,"lon":101},{"facility":105,"status":106,"city":107,"state":20,"zip":20,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Karolinska University Hospital","NOT_YET_RECRUITING","Stockholm","Sweden","SE",{"type":64,"coordinates":111},[112,113],18.06871,59.32938,{"lat":113,"lon":112},[116,118],{"name":117,"role":49,"phone":20,"phoneExt":20,"email":20},"Marcus Stahlberg, MD",{"name":117,"role":45,"phone":20,"phoneExt":20,"email":20},{"type":120,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[122,124,126,128,130,132,134,135,137,139],{"name":123,"class":23},"Dignity Health",{"name":82,"class":125},"UNKNOWN",{"name":127,"class":23},"Arizona State University",{"name":129,"class":23},"University of Arizona",{"name":131,"class":125},"University of Phoenix College of Nursing",{"name":133,"class":125},"Creighton School of Medicine, Phoenix Arizona",{"name":105,"class":23},{"name":136,"class":125},"Partnership for Economic Innovation Arizona",{"name":138,"class":125},"Kanasu Labs",{"name":140,"class":6},"Intel Corporation","100623979","cardiovascular-kidney-and-metabolic-health-assessment-and-patient-empowerment-100623979",false,"NCT07403669","Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment","Cardiovascular Kidney and Metaboolic (CKM) Health Assessment and Patient Empowerment in chROnic Disease Using a Health Coach INtervention ModEl: A Randomized Clinical Trial","CHAPERONE-CKM","Inclusion Criteria:\n\n* Men and women over 18 years of age are included\n* Eligible subjects must have one of the risk factor\u002F disease component of CKM:\n* Diabetes with A1C of 7.5 or higher;\n* or Heart disease with stent placement;\n* or Coronary Artery Bypass Graft (CABG) in the last 12 months;\n* or Chronic Kidney Disease (CKD) stage 2- 4\n* and, in those with Heart failure, a recent hospitalization within one week of enrollment is required\n\nExclusion Criteria:\n\n* Those subjects who are not willing to sign an informed consent","ALL","18 Years",{"count":152,"type":153},300,"ESTIMATED","INTERVENTIONAL",[156],"NA","The primary objective of CHAPERONE solution is to evaluate the efficacy of engaging, assessing, and enabling long term treatment strategy with Health Artificial Intelligence (AI) Chatbot, Copilot, Large Language Model (LLM) and vital sign monitoring device in reducing CKM disease burden using an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment.",[159,160,161,162],"Acute MI","Heart Failure","Diabetes Mellitus","Kidney Disease","2026-02-10",{"date":165,"type":166},"2026-02-12","ACTUAL",{"date":168,"type":166},"2025-10-22",{"date":170,"type":153},"2027-04-22",{"name":5,"class":6},5]