Clinical, Biochemical and Genetic Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients (CKDCS/LUCID)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Coronary Artery Calcification
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 18 years of age) commencing hemodialysis or peritoneal dialysis.
排除标准
- •Unable to provide informed consent.
- •Exclusion Criteria for the cardiac substudy:
- •CT exclusion criteria
- •Obesity (>275 lbs)
- •Rapid atrial fibrillation, bigeminy or trigeminy
- •Any condition that impedes the ability to lie flat during the CT (eg:decompensated congestive heart failure).
- •MRI exclusion criteria
- •Cardiac pacemaker or implantable defibrillator
- •Obesity (>275lbs)
- •Intraocular metal
- •Cerebral aneurysm clips, programmable shunt, etc.
- •Any type of ear implant
- •Any implanted device (eg: insulin, drug infusion device)
- •Metal shrapnel or bullet
- •Any condition that impedes the ability to lie flat during the MRI (eg:decompensated congestive heart failure)
结局指标
主要结局
Coronary Artery Calcification
时间窗: baseline
次要结局
- Left ventricular hypertrophy(baseline)
- Coronary Artery Calcification(12 months)
- Left ventricular mass(12 months)
- All cause mortality(12 months)
研究者
Marcello Tonelli
MD, Associate Professor
University of Alberta
