Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients



Status:Terminated
Conditions:Renal Impairment / Chronic Kidney Disease, Cardiology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:5/3/2018
Start Date:May 2011
End Date:December 2017

Use our guide to learn which trials are right for you!

Clinical, Biochemical and Genetic Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients (CKDCS/LUCID)

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).

Inclusion Criteria:

- Adults (≥ 18 years of age) commencing hemodialysis or peritoneal dialysis.

Exclusion Criteria:

• Unable to provide informed consent.

Exclusion Criteria for the cardiac substudy:

CT exclusion criteria

1. Pregnancy

2. Obesity (>275 lbs)

3. Rapid atrial fibrillation, bigeminy or trigeminy

4. Any condition that impedes the ability to lie flat during the CT (eg:decompensated
congestive heart failure).

MRI exclusion criteria

1. Cardiac pacemaker or implantable defibrillator

2. Obesity (>275lbs)

3. Intraocular metal

4. Cerebral aneurysm clips, programmable shunt, etc.

5. Any type of ear implant

6. Any implanted device (eg: insulin, drug infusion device)

7. Metal shrapnel or bullet

8. Any condition that impedes the ability to lie flat during the MRI (eg:decompensated
congestive heart failure)
We found this trial at
4
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Edmonton, Alberta T6G 2J2
?
mi
from
Edmonton,
Click here to add this to my saved trials
340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials