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Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time (CanPREDDICT)

2013年11月27日更新者：University of British Columbia

CanPREDDICT: Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time

This study will follow 2500 prevalent Chronic Kidney Disease (CKD) patients with Glomerular Filtration Rate (GFR) from 15-45 ml/min for 30 months with serial measurements every 6 months and subsequent annual chart review up to 60 months. This observational study will analyze the demographics, clinical status, medications and blood and urine samples of these patients and study the conventional biochemical, hormonal and metabolic parameters assessing which underlying biomarkers reflect the processes involved with disease progression.

研究概览

地位

未知

条件

慢性肾病

研究类型

观察性的

注册 (实际的)

2602

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

加拿大
- Alberta
  - Calgary、Alberta、加拿大
    - Foothills Hospital
  - Edmonton、Alberta、加拿大
    - University of Alberta
- British Columbia
  - Penticton、British Columbia、加拿大
    - Penticton Regional Hospital
  - Vancouver、British Columbia、加拿大
    - Vancouver General Hospital
  - Vancouver、British Columbia、加拿大
    - BC Children's Hospital
  - Vancouver、British Columbia、加拿大
    - St. Paul's Hospital
- Manitoba
  - Winnipeg、Manitoba、加拿大
    - St. Boniface Hospital
- Newfoundland and Labrador
  - St John's、Newfoundland and Labrador、加拿大
    - Eastern Regional Health Authority, Health Sciences Centre
- Nova Scotia
  - Halifax、Nova Scotia、加拿大
    - QEII Health Sciences Centre
  - Sydney、Nova Scotia、加拿大
    - Cape Breton District Health Authority
- Ontario
  - Hamilton、Ontario、加拿大
    - St Joseph's Hospital
  - Kingston、Ontario、加拿大
    - Kingston General Hospital
  - London、Ontario、加拿大
    - London Health Science Centre- Victoria Campus
  - London、Ontario、加拿大
    - London Health Science Centre- University Campus
  - Oak Ridges、Ontario、加拿大
    - York Central
  - Ottawa、Ontario、加拿大
    - University of Ottawa
  - Timmins、Ontario、加拿大
    - Timmins & District Hospital
  - Toronto、Ontario、加拿大
    - St. Michael's Hospital
  - Toronto、Ontario、加拿大
    - University Health Network
  - Toronto、Ontario、加拿大
    - Sunnybrook Hospital
- Quebec
  - Greenfield Park、Quebec、加拿大
    - Charles Le Moyne Hospital
  - Montreal、Quebec、加拿大
    - Royal Victoria Hospital
  - Montreal、Quebec、加拿大
    - Hopital Du Sacre-Coeur
  - Montréal、Quebec、加拿大
    - Maisonneuve-Rosemont Hopital
  - Quebec City、Quebec、加拿大
    - CHUQ: L'Hôtel-Dieu de Québec

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Nephrology Clinics across Canada

描述

Inclusion Criteria:

Patients currently seen by a nephrologist, or referred for evaluation of CKD
GFR between 15-45 ml/min
Adults 19 years (depending on age of consent in province) or older
At pediatric sites study participants will be eligible to participate at age 15 or older

Exclusion Criteria:

Organ transplant recipient
Life expectancy less than 12 months
Acute Vasculitis
Bioimpedance sub-study exclusion criteria:
Amputation (readings are inaccurate)
Any battery operated or electronic implanted device (such as pacemaker or implanted defibrillator - potential electrical hazard)
Pregnant women

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Bioimpedance sub-study cohort Funded by a grant from Kidney Foundation of Canada, Dr. Catherine Clase initiated a bioimpedance sub-study across 7 centres and recruited n=416 within the CANPREDDICT population. The study uses bioimpedance measurements to assess volume status to determine the multivariable relationship between baseline volume overload and subsequent cardiovascular events. Subjects are followed at 6 months intervals for 2 years.
Ethnic enrichment cohort Additional recruitment initiated and funded by the Principal Investigator, Adeera Levin for enriching the ethnic representation within the Canadian cohort on South Asian and Oriental Asian was completed from Sept 2012 to June 2013, n=53.
Original CanPreddict cohort The original CanPreddict cohort was recruited from Jun 2008 - Oct 2009 has 2544 CKD patients across Canada.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Renal Replacement Therapy 大体时间：6 monthly for 3 years, annually up to 5 years	Renal Replacement Therapy is defined as dialysis start or transplantation.	6 monthly for 3 years, annually up to 5 years
Cardiovascular events 大体时间：6 monthly for 3 years, annually up to 5 years	Cardiovascular events are defined as myocardial infarction, ischemic and hemorrhagic stroke, coronary revascularization, congestive heart failure, peripheral bypass and gangrenes, adjudicated by a nephrologist, cardiologist and neurologist.	6 monthly for 3 years, annually up to 5 years
Death 大体时间：6 monthly for 3 years, annually up to 5 years	Deaths are reported with source documentation and adjudicated for ischemic or congestive cardiovascular death, other cardiovascular death, non-cardiovascular death and unknown cause of death.	6 monthly for 3 years, annually up to 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of British Columbia

调查人员

首席研究员：Adeera Levin、University of British Columbia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Levin A, Rigatto C, Brendan B, Madore F, Muirhead N, Holmes D, Clase CM, Tang M, Djurdjev O; CanPREDDICT investigators. Cohort profile: Canadian study of prediction of death, dialysis and interim cardiovascular events (CanPREDDICT). BMC Nephrol. 2013 Jun 11;14:121. doi: 10.1186/1471-2369-14-121.
Levin A, Rigatto C, Barrett B, Madore F, Muirhead N, Holmes D, Clase C, Tang M, Djurdjev O. (2012). Canadian study of prediciont of death, dialysis and interim cardiovascular events: CanPREDDICT: Biomarkers improve prediction of one year outcomes in chronic kidney disease cohort. Clinical studies in CKD. Nephrology Dialysis Transplantation, 27(suppl 2), ii63-ii65.
Levin A, Rigatto C, Barrett B, Madore F, Muirhead N, Holmes D, Clase CM, Tang M, Djurdjev O; CanPREDDICT Investigators. Biomarkers of inflammation, fibrosis, cardiac stretch and injury predict death but not renal replacement therapy at 1 year in a Canadian chronic kidney disease cohort. Nephrol Dial Transplant. 2014 May;29(5):1037-47. doi: 10.1093/ndt/gft479. Epub 2013 Dec 26.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年6月1日

初级完成 (预期的)

2014年12月1日

研究完成 (预期的)

2014年12月1日

研究注册日期

首次提交

2009年1月20日

首先提交符合 QC 标准的

2009年1月21日

首次发布 (估计)

2009年1月22日

研究记录更新

最后更新发布 (估计)

2013年11月28日

上次提交的符合 QC 标准的更新

2013年11月27日

最后验证

2013年11月1日