Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients
Individuals with kidney disease are at a higher risk for heart and vascular diseases, including heart attacks and strokes, than those with normal kidney function. The purpose of this research study is to collect information on the causes, complications and treatment of kidney disease. Patient characteristics, comorbid diseases and laboratory markers used in routine practice, as well as novel biochemical markers and genetic data will be collected to examine relationships between biochemical and genetic markers and cardiovascular risk. Information on the health history of incident hemodialysis and peritoneal dialysis patients will be captured using structured patient interviews and review of medical records. Blood and urine specimens will be collected at the time of dialysis initiation and stored in order to perform novel biochemical and genetic assays in the future. The overall goal of the CKDCS/LUCID study is improve understanding of cardiac-associated risks and to improve treatment in patients with kidney disease. A cardiac imaging substudy will be performed in a subset of patients enrolled. The goals of the substudy are to examine whether the risks of developing common cardiac-related complications (coronary artery calcification [CAC] and left ventricular hypertrophy [LVH]) are associated with certain medications taken by individuals on dialysis and whether these risks are modified by a genotypic predisposition.
End Stage Renal Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Clinical, Biochemical and Genetic Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients (CKDCS/LUCID)|
- Coronary Artery Calcification [ Time Frame: baseline ] [ Designated as safety issue: No ]
- Coronary Artery Calcification [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Left ventricular mass [ Time Frame: baseline ] [ Designated as safety issue: No ]
- Left ventricular mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- All cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Left ventricular hypertrophy [ Time Frame: baseline ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood and urine will be obtained at baseline, 6 months and annually thereafter. Blood samples will be immediately divided into multiple aliquots, from which plasma, DNA, RNA and/or cells will be extracted and separately stored. Urine specimens will also be aliquoted to allow future measurement of genetic and cellular material. Specimens will be labeled using unique study identifiers to maintain confidentiality.
|Study Start Date:||May 2011|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
This study is being conducted under the Sponsorship of the University of Alberta (Edmonton, Alberta, Canada) and is funded by Canadian Institutes of Health Industry Partnered Research Grant IRO 90262 - with partnership funding from Abbott Laboratories. The co-Principal Investigators are Marcello Tonelli MD SM and Ravi Thadhani, MD, MPH . A total of 750 patients are anticipated being enrolled at Massachusetts General Hospital (MGH) (with 250 in the cardiac imaging substudy). The remaining patients are being enrolled in Canada.
This study will utilize data from "The Canadian Kidney Disease Cohort Study" (CKDCS) and "The Longitudinal US/Canada Incident Dialysis STUDY (LUCID).
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States|
|Contact: Dorrie Sullivan, RN 617-726-5382 DSULLIVAN18@PARTNERS.ORG|
|Sub-Investigator: Ishir Bhan, MD|
|Sub-Investigator: Sagar Nigwekar, MD|
|Sub-Investigator: Chunmei Huang, MD|
|Principal Investigator: Ravi Thadhani, MD|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada|
|Contact: Dawn Opgenorth, RN 780-407-1543 email@example.com|
|Sub-Investigator: Richard Coulden, MD, MRCP|
|Principal Investigator: Marcello Tonelli, MD, FRCP|
|Principal Investigator:||Ravi Thadhani, MD, MPH||Massachusetts General Hospital|
|Principal Investigator:||Marcello Tonelli, MD, SM, FRCP||University of Alberta|