Rationale and study design of the prospective, longitudinal, observational cohort study “rISk strAtification in end-stage renal disease” (ISAR) study

BMC Nephrology

Study Protocol

Marcus Baumann¹  Stephan Kemmner¹  Christoph Schmaderer¹  Uwe Heemann¹  Christine Hauser¹  Susanne Tholen¹  Lutz Renders¹  Anna-Lena Hasenau¹  Yana Suttmann¹  Konstantin Kotliar²  Siegfried Wassertheurer³  Christopher C. Mayer³  Bernhard Haller⁴  Kostantinos D. Rizas⁵  Axel Bauer⁵  Johannes Mann⁶ 

[1] Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany;FH Aachen, University of applied sciences, Heinrich-Mussmann-Str. 1, 52428, Jülich, Germany;Health & Environment Department, AIT Austrian Institute of Technology GmbH, Biomedical Systems, Donau-City-Str. 1, 1220, Vienna, Austria;Institute of medical statistics and epidemiology (IMSE), Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany;Medizinische Klinik und Poliklinik I, Department of Cardiology, Klinikum Großhadern, Ludwig-Maximilians-Universität München, Marchioninistr. 15, 81377, Munich, Germany;Städtisches Klinikum Schwabing, KFH Dialysezentrum Schwabing, Kölner Platz 1, 80804, Munich, Germany;

关键词: End stage renal disease;    Pulse wave velocity (PWV);    Pulse wave analysis (PWA);    Montreal Cognitive Assessment (MoCA);    Risk stratification;    ISAR;    Ambulatory blood pressure monitoring (ABPM);    retinal vessel analysis (RVA);    Hemodialysis;    Dialysis;   

DOI  :  10.1186/s12882-016-0374-8

 received in 2015-10-12, accepted in 2016-10-15,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe 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.Methods/designWe 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.Discussion/conclusionWe 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.Clinical trials identifierClinicalTrials.gov NCT01152892 (June 28, 2010)

【 授权许可】

CC BY   
© The Author(s). 2016