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| ID | Type | Description | Link |
|---|---|---|---|
| IRO 90262 | Other Grant/Funding Number | Canadian Institutes of Health Research |
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low recruitment
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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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.
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). 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).
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| Measure | Description | Time Frame |
|---|---|---|
| Coronary Artery Calcification | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary Artery Calcification | 12 months | |
| Left ventricular mass | baseline | |
| Left ventricular mass |
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Inclusion Criteria:
Exclusion Criteria:
• Unable to provide informed consent.
Exclusion Criteria for the cardiac substudy:
CT exclusion criteria
MRI exclusion criteria
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Incident hemodialysis and peritoneal dialysis patients
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Thadhani, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Marcello Tonelli, MD, SM, FRCP | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States | ||
| Massachusetts General Hospital |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| D017379 | Hypertrophy, Left Ventricular |
| D020022 | Genetic Predisposition to Disease |
| D007239 | Infections |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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.
| 12 months |
| All cause mortality | 12 months |
| Left ventricular hypertrophy | baseline |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| University of Washington | Seattle | Washington | 98195U | United States |
| University of Alberta | Edmonton | Alberta | Canada |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D004198 | Disease Susceptibility |