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.
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. Patients 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/or doubling of serum creatinine with decrease of eGFR to less than 45 ml/min./1.73m2 (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. The 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. With 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). With 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.
Study Type
OBSERVATIONAL
Enrollment
6,000
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, Poland
RECRUITINGSamodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach
Zabrze, Poland
RECRUITINGIncident Coronary Artery Disease
New occurrence of coronary artery disease as diagnosed by standard medical procedures.
Time frame: Annually, 10 years from enrollment
Myocardial Infarction
New occurrence of myocardial infarction as confirmed by electrocardiogram and/or biomarkers.
Time frame: Annually, 10 years from enrollment
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. Hospitalization for decompensated heart failure: Requires unscheduled admission to a healthcare facility with heart failure as the primary reason for admission.
Time frame: Annually, 10 years from enrollment
Stroke or Transient Ischemic Attack
New occurrence of stroke as confirmed by neuroimaging or transient ischemic attack ascertained by typical symptoms.
Time frame: Annually, 10 years from enrollment
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.
Time frame: Annually, 10 years from enrollment
Atrial Fibrillation
Incident atrial fibrillation confirmed by electrocardiogram.
Time frame: Annually, 10 years from enrollment
Death Due to Cardiovascular Cause
Death where the primary cause is attributed to cardiovascular disease.
Time frame: Annually, 10 years from enrollment
Progression of Chronic Kidney Disease
Progression to macroalbuminuria or doubling of serum creatinine with a decrease of eGFR to less than 45 ml/min/1.73m\^2 compared to baseline.
Time frame: Annually, 10 years from enrollment
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.
Time frame: Annually, 10 years from enrollment
Machine-learning predictors of outcomes, including ECG predictors and retinal imaging predictors.
Using new statistical methods in predicting outcomes
Time frame: 10 years from enrollment
Cluster analyses.
Use of statistical cluster analysis to identify patterns within primary outcome measures.
Time frame: 10 years from enrollment
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