title: Rationale and study design of the prospective, longitudinal, observational cohort study "rISk strAtification in end-stage renal disease" (ISAR) study.
abstract: The ISAR study is a prospective, longitudinal, observational cohort study to improve the cardiovascular risk stratification in endstage renal disease (ESRD). The major goal is to characterize the cardiovascular phenotype of the study subjects, namely alterations in micro- and macrocirculation and to determine autonomic function.
  
  
  
  We intend to recruit 500 prevalent dialysis patients in 17 centers in Munich and the surrounding area. Baseline examinations include: (1) biochemistry, (2) 24-h Holter Electrocardiography (ECG) recordings, (3) 24-h ambulatory blood pressure measurement (ABPM), (4) 24 h pulse wave analysis (PWA) and pulse wave velocity (PWV), (5) retinal vessel analysis (RVA) and (6) neurocognitive testing. After 24 months biochemistry and determination of single PWA, single PWV and neurocognitive testing are repeated. Patients will be followed up to 6 years for (1) hospitalizations, (2) cardiovascular and (3) non-cardiovascular events and (4) cardiovascular and (5) all-cause mortality.
  
  
  
  We aim to create a complex dataset to answer questions about the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients. Finally we hope to improve cardiovascular risk stratification in comparison to the use of classical and non-classical (dialysis-associated) risk factors and other models of risk stratification in ESRD patients by building a multivariable Cox-Regression model using a combination of the parameters measured in the study.
  
  
  
  ClinicalTrials.gov NCT01152892 (June 28, 2010).
authors: Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany. christoph.schmaderer@mri.tum.de.
authors: Christoph
authors: C
authors: Schmaderer
authors: Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
authors: Susanne
authors: S
authors: Tholen
authors: Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
authors: Anna-Lena
authors: AL
authors: Hasenau
authors: Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
authors: Christine
authors: C
authors: Hauser
authors: Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
authors: Yana
authors: Y
authors: Suttmann
authors: Health & Environment Department, AIT Austrian Institute of Technology GmbH, Biomedical Systems, Donau-City-Str. 1, 1220, Vienna, Austria.
authors: Siegfried
authors: S
authors: Wassertheurer
authors: Health & Environment Department, AIT Austrian Institute of Technology GmbH, Biomedical Systems, Donau-City-Str. 1, 1220, Vienna, Austria.
authors: Christopher C
authors: CC
authors: Mayer
authors: Medizinische Klinik und Poliklinik I, Department of Cardiology, Klinikum Großhadern, Ludwig-Maximilians-Universität München, Marchioninistr. 15, 81377, Munich, Germany.
authors: Axel
authors: A
authors: Bauer
authors: Medizinische Klinik und Poliklinik I, Department of Cardiology, Klinikum Großhadern, Ludwig-Maximilians-Universität München, Marchioninistr. 15, 81377, Munich, Germany.
authors: Kostantinos D
authors: KD
authors: Rizas
authors: Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
authors: Stephan
authors: S
authors: Kemmner
authors: FH Aachen, University of applied sciences, Heinrich-Mussmann-Str. 1, 52428, Jülich, Germany.
authors: Konstantin
authors: K
authors: Kotliar
authors: Institute of medical statistics and epidemiology (IMSE), Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
authors: Bernhard
authors: B
authors: Haller
authors: Städtisches Klinikum Schwabing, KFH Dialysezentrum Schwabing, Kölner Platz 1, 80804, Munich, Germany.
authors: Johannes
authors: J
authors: Mann
authors: Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
authors: Lutz
authors: L
authors: Renders
authors: Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
authors: Uwe
authors: U
authors: Heemann
authors: Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
authors: Marcus
authors: M
authors: Baumann
mesh_terms: D002318:Cardiovascular Diseases / Q000150:complications* / Q000401:mortality / Q000503:physiopathology; D002423:Cause of Death; D004562:Electrocardiography; D005767:Gastrointestinal Diseases / Q000401:mortality; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007239:Infections / Q000401:mortality; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000503:physiopathology / Q000628:therapy; D008137:Longitudinal Studies; D008171:Lung Diseases / Q000401:mortality; D009369:Neoplasms / Q000401:mortality*; D009483:Neuropsychological Tests; D010641:Phenotype; D011446:Prospective Studies; D063177:Pulse Wave Analysis; D006435:Renal Dialysis; D012107:Research Design; D012171:Retinal Vessels / Q000000981:diagnostic imaging; D018570:Risk Assessment; D014947:Wounds and Injuries / Q000401:mortality
keywords: Ambulatory blood pressure monitoring (ABPM); Dialysis; End stage renal disease; Hemodialysis; ISAR; Montreal Cognitive Assessment (MoCA); Pulse wave analysis (PWA); Pulse wave velocity (PWV); Risk stratification; retinal vessel analysis (RVA)