[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522480":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":49,"studyPopulation":50,"armGroups":45,"interventions":45,"overallOfficials":51,"centralContacts":64,"locations":71,"responsibleParty":128,"collaborators":130,"id":134,"slug":45,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":45,"eligibilityCriteria":138,"healthyVolunteers":135,"sex":139,"minAge":140,"maxAge":45,"enrollmentInfo":141,"targetDuration":45,"studyType":144,"phases":45,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":74,"whyStopped":45,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Medical University of Silesia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":37,"otherOutcomes":45},[9,13,16,19,22,25,28,31,34],{"measure":10,"description":11,"timeFrame":12},"Incident Coronary Artery Disease","New occurrence of coronary artery disease as diagnosed by standard medical procedures.","Annually, 10 years from enrollment",{"measure":14,"description":15,"timeFrame":12},"Myocardial Infarction","New occurrence of myocardial infarction as confirmed by electrocardiogram and\u002For biomarkers.",{"measure":17,"description":18,"timeFrame":12},"New onset heart failure or exacerbation of heart failure","New-Onset Heart Failure: Diagnosis based on the ESC guidelines, which include symptoms such as breathlessness, ankle swelling, and fatigue; objective evidence of cardiac dysfunction or structural abnormality in echocardiography; and response to treatment directed towards heart failure.\n\nHospitalization for decompensated heart failure: Requires unscheduled admission to a healthcare facility with heart failure as the primary reason for admission.",{"measure":20,"description":21,"timeFrame":12},"Stroke or Transient Ischemic Attack","New occurrence of stroke as confirmed by neuroimaging or transient ischemic attack ascertained by typical symptoms.",{"measure":23,"description":24,"timeFrame":12},"Peripheral Vascular Disease Peripheral Vascular Disease Peripheral Vascular Disease Peripheral Vascular Disease Peripheral Vascular Disease","New diagnosis of peripheral vascular disease confirmed by imaging studies.",{"measure":26,"description":27,"timeFrame":12},"Atrial Fibrillation","Incident atrial fibrillation confirmed by electrocardiogram.",{"measure":29,"description":30,"timeFrame":12},"Death Due to Cardiovascular Cause","Death where the primary cause is attributed to cardiovascular disease.",{"measure":32,"description":33,"timeFrame":12},"Progression of Chronic Kidney Disease","Progression to macroalbuminuria or doubling of serum creatinine with a decrease of eGFR to less than 45 ml\u002Fmin\u002F1.73m\\^2 compared to baseline.",{"measure":35,"description":36,"timeFrame":12},"End-Stage Renal Disease or Renal Death","Onset of end-stage renal disease requiring initiation of maintenance dialysis or kidney transplantation, or death due to renal causes.",[38,42],{"measure":39,"description":40,"timeFrame":41},"Machine-learning predictors of outcomes, including ECG predictors and retinal imaging predictors.","Using new statistical methods in predicting outcomes","10 years from enrollment",{"measure":43,"description":44,"timeFrame":41},"Cluster analyses.","Use of statistical cluster analysis to identify patterns within primary outcome measures.",null,{"allocation":45,"interventionModel":45,"interventionModelDescription":45,"primaryPurpose":45,"observationalModel":47,"timePerspective":48,"maskingInfo":45},"COHORT","PROSPECTIVE","This is a prospective, observational study seeking to collate demographic, laboratory, and clinical data from patients with CKD hospitalized at two academic centres: the Department of Internal Medicine, Diabetology and Nephrology in Zabrze, Silesia, and the Clinic of Nephrology, Hypertension and Internal Medicine in Olsztyn, Warmia and Mazury.\n\nPatients will receive telephone check-ups annually post-discharge and will be proposed to attend on-site follow-up health checks. Patients will be followed up annually for 10 years or until death if occurs earlier, in order to collect information related to new onset cardiovascular events and progression to macroalbuminuria and\u002For doubling of serum creatinine with decrease of eGFR to less than 45 ml\u002Fmin.\u002F1.73m2 (compared to baseline) or the onset of end stage renal disease (ESRD) or renal death. ESRD is defined as initiation of maintenance dialysis or kidney transplantation. All procedures, except eye fundus imaging for hospitalized patients align with standard nephrology ward care that patients agree for upon hospitalization.\n\nThe Medical University of Silesia and the University of Warmia and Mazury, Collegium Medicum obtained study approvals from the respective independent university- or chamber of physicians-based bioethics committees for performing fundus imaging during hospital stay and annual telephone contacts as well as on- site health checks for the longitudinal patient follow-up observation.\n\nWith patient consent, annual on-site visits will entail blood and urine assessments, ECG, retinal imaging via the fundus camera, and examinations for peripheral and cardiac autonomic neuropathy among those with diabetes. Biochemical analyses will focus on assessing serum creatinine, lipid profile, HbA1c for diabetic patients, and the urine albumin-creatinine ratio (UACR).\n\nWith a decade-long prospective follow-up focused on documenting new cardiovascular and renal events, the primary objective is to identify patients with CKD at the highest risk of cardiovascular disease and CKD progression. This goal will be achieved by implementing machine learning techniques to analyze clinical parameters that are easy to obtain in everyday clinical practice.","Patients hospitalized in nephrology departments in Zabrze and Olsztyn.",[52,55,58,62],{"name":53,"affiliation":5,"role":54},"Katarzyna Nabrdalik, assoc. Prof","PRINCIPAL_INVESTIGATOR",{"name":56,"affiliation":57,"role":54},"Tomasz Stompór, Prof.","The University of Warmia and Mazury in Olsztyn",{"name":59,"affiliation":60,"role":61},"Gregory YH Lip, Prof.","University of Liverpool","STUDY_CHAIR",{"name":63,"affiliation":5,"role":61},"Janusz Gumprecht, Prof.",[65,69],{"name":53,"role":66,"phone":67,"phoneExt":45,"email":68},"CONTACT","0048323704438","knabrdalik@sum.edu.pl",{"name":56,"role":66,"phone":45,"phoneExt":45,"email":70},"stompin@mp.pl",[72,101],{"facility":73,"status":74,"city":75,"state":45,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Wojewódzki Szpital Specjalistyczny w Olsztynie","RECRUITING","Olsztyn","10-561","Poland","PL",{"type":80,"coordinates":81},"Point",[82,83],20.49272,53.78376,{"lat":83,"lon":82},[86,89,90,93,95,97,99],{"name":87,"role":66,"phone":88,"phoneExt":45,"email":70},"Tomasz Stompór, Prof","0048 89 538 6229",{"name":56,"role":54,"phone":45,"phoneExt":45,"email":45},{"name":91,"role":92,"phone":45,"phoneExt":45,"email":45},"Paulina Dziamałek - Macioszczyk","SUB_INVESTIGATOR",{"name":94,"role":92,"phone":45,"phoneExt":45,"email":45},"Agata Winiarska, PhD",{"name":96,"role":92,"phone":45,"phoneExt":45,"email":45},"Zuzanna Smuniewska",{"name":98,"role":92,"phone":45,"phoneExt":45,"email":45},"Tomasz Maroszczuk",{"name":100,"role":92,"phone":45,"phoneExt":45,"email":45},"Janusz Pieczyński",{"facility":102,"status":74,"city":103,"state":45,"zip":104,"country":77,"countryCode":78,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach","Zabrze","41-800",{"type":80,"coordinates":106},[107,108],18.78576,50.32492,{"lat":108,"lon":107},[111,114,118,119,121,122,124,126],{"name":112,"role":66,"phone":113,"phoneExt":45,"email":68},"Katarzyna Nabrdalik, assoc. Prof.","0048697592954",{"name":115,"role":66,"phone":116,"phoneExt":45,"email":117},"Hanna Kwiendacz, PhD","0048509774849","hkwiendacz@sum.edu.pl",{"name":53,"role":54,"phone":45,"phoneExt":45,"email":45},{"name":120,"role":92,"phone":45,"phoneExt":45,"email":45},"Janusz Gumprecht, Prof",{"name":115,"role":92,"phone":45,"phoneExt":45,"email":45},{"name":123,"role":92,"phone":45,"phoneExt":45,"email":45},"Krzysztof Irlik",{"name":125,"role":92,"phone":45,"phoneExt":45,"email":45},"Mirela Hendel",{"name":127,"role":92,"phone":45,"phoneExt":45,"email":45},"Julia Piaśnik",{"type":129,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[131,133],{"name":132,"class":6},"University of Warmia and Mazury in Olsztyn",{"name":60,"class":6},"100522480",false,"NCT06083168","Cardiovascular Disease in Patients With Chronic Kidney Disease: Polish Kidney- Heart Project","Inclusion Criteria:\n\n* CKD defined as estimated glomerular filtration rate (eGFR) \\\u003C 60ml\u002Fmin\u002F1.73 m2 and\u002For urine albumin creatinine ratio ( UACR) \\> 30 mg\u002Fg lasting at least 3 months\n* CKD regardless of eGFR\u002Falbuminuria when documented otherwise (by means of imaging, renal biopsy result, genetic background, etc)\n\nExclusion Criteria:\n\n* Death during hospital stay\n* Terminal stage of cancer\n* Lack of an informed consent","ALL","18 Years",{"count":142,"type":143},6000,"ESTIMATED","OBSERVATIONAL","This is an observational longitudinal study which will collect routine demographic, laboratory and clinical parameters of patients with chronic kidney disease (CKD) in the Silesian and Warmia and Mazury Regions (Poland) aimed at predicting incident cardiovascular disease and cardiovascular and renal events using machine learning and artificial intelligence approaches. There will be a subgroup analysis of patients with diabetes and CKD.",[147,148],"Chronic Kidney Disease","Cardiovascular Diseases",[150,151,152,153],"chronic kidney disease","cardiovascular disease","artificial inteligence","predictors","2024-04-30",{"date":156,"type":157},"2024-05-02","ACTUAL",{"date":159,"type":157},"2023-12-01",{"date":161,"type":143},"2036-01-31",{"name":5,"class":6},2]