title: Rationale and design for the Predictors of Arrhythmic and Cardiovascular Risk in End Stage Renal Disease (PACE) study.
abstract: BACKGROUND
  Sudden cardiac death occurs commonly in the end-stage renal disease population receiving dialysis, with 25% dying of sudden cardiac death over 5 years. Despite this high risk, surprisingly few prospective studies have studied clinical- and dialysis-related risk factors for sudden cardiac death and arrhythmic precursors of sudden cardiac death in end-stage renal disease.
  
  
  METHODS
  We present a brief summary of the risk factors for arrhythmias and sudden cardiac death in persons with end-stage renal disease as the rationale for the Predictors of Arrhythmic and Cardiovascular Risk in End Stage Renal Disease (PACE) study, a prospective cohort study of patients recently initiated on chronic hemodialysis, with the overall goal to understand arrhythmic and sudden cardiac death risk. Participants were screened for eligibility and excluded if they already had a pacemaker or an automatic implantable cardioverter defibrillator. We describe the study aims, design, and data collection of 574 incident hemodialysis participants from the Baltimore region in Maryland, U.S.A.. Participants were recruited from 27 hemodialysis units and underwent detailed clinical, dialysis and cardiovascular evaluation at baseline and follow-up. Cardiovascular phenotyping was conducted on nondialysis days with signal averaged electrocardiogram, echocardiogram, pulse wave velocity, ankle, brachial index, and cardiac computed tomography and angiography conducted at baseline. Participants were followed annually with study visits including electrocardiogram, pulse wave velocity, and ankle brachial index up to 4 years. A biorepository of serum, plasma, DNA, RNA, and nails were collected to study genetic and serologic factors associated with disease.
  
  
  CONCLUSIONS
  Studies of modifiable risk factors for sudden cardiac death will help set the stage for clinical trials to test therapies to prevent sudden cardiac death in this high-risk population.
authors.affiliation: Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, USA. rulan.parekh@sickkids.ca.|Department of Epidemiology, Bloomberg School of Public Health|, Johns Hopkins University, Baltimore, USA. rulan.parekh@sickkids.ca.|Departments of Paediatrics and Medicine, Hospital for Sick Children, University Health Network and University of Toronto, Toronto, ON, Canada. rulan.parekh@sickkids.ca.
authors.forename: Rulan S
authors.initials: RS
authors.lastname: Parekh
authors.affiliation: Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, USA. lmeoni@jhsph.edu.|Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, USA. lmeoni@jhsph.edu.|Welch Center for Prevention, Epidemiology, and Clinical Research, Baltimore, USA. lmeoni@jhsph.edu.
authors.forename: Lucy A
authors.initials: LA
authors.lastname: Meoni
authors.affiliation: Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, USA. bjaar@jhmi.edu.|Department of Epidemiology, Bloomberg School of Public Health|, Johns Hopkins University, Baltimore, USA. bjaar@jhmi.edu.|Welch Center for Prevention, Epidemiology, and Clinical Research, Baltimore, USA. bjaar@jhmi.edu.|Nephrology Center of Maryland, Baltimore, USA. bjaar@jhmi.edu.
authors.forename: Bernard G
authors.initials: BG
authors.lastname: Jaar
authors.affiliation: Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, USA. ssozio@jhmi.edu.|Department of Epidemiology, Bloomberg School of Public Health|, Johns Hopkins University, Baltimore, USA. ssozio@jhmi.edu.
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Sozio
authors.affiliation: Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, USA. tshafi@jhmi.edu.
authors.forename: Tariq
authors.initials: T
authors.lastname: Shafi
authors.affiliation: Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, USA. gtomasel@jhmi.edu.
authors.forename: Gordon F
authors.initials: GF
authors.lastname: Tomaselli
authors.affiliation: Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, USA. jlima@jhmi.edu.
authors.forename: Joao A
authors.initials: JA
authors.lastname: Lima
authors.affiliation: Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, USA. tereshch@ohsu.edu.|Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA. tereshch@ohsu.edu.
authors.forename: Larisa G
authors.initials: LG
authors.lastname: Tereshchenko
authors.affiliation: Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, USA. mestrel1@jhmi.edu.
authors.forename: Michelle M
authors.initials: MM
authors.lastname: Estrella
authors.affiliation: Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, USA. wkao@jhsph.edu.|Department of Epidemiology, Bloomberg School of Public Health|, Johns Hopkins University, Baltimore, USA. wkao@jhsph.edu.|Welch Center for Prevention, Epidemiology, and Clinical Research, Baltimore, USA. wkao@jhsph.edu.
authors.forename: W H Linda
authors.initials: WH
authors.lastname: Kao
mesh_terms: D000328:Adult; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000453:epidemiology*; D002318:Cardiovascular Diseases / Q000453:epidemiology; D015331:Cohort Studies; D016757:Death, Sudden, Cardiac / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000453:epidemiology* / Q000628:therapy; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis; D018570:Risk Assessment; D012307:Risk Factors; D014481:United States