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

NCT ID: NCT01427374

Last Updated: 2018-05-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2017-12-31

Brief Summary

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.

Detailed Description

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).

Conditions

End Stage Renal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Unable to provide informed consent.

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).

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Responsible Party

Marcello Tonelli

MD, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ravi Thadhani, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Marcello Tonelli, MD, SM, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Washington

Seattle, Washington, United States

University of Alberta

Edmonton, Alberta, Canada

Countries

United States; Canada

Other Identifiers

IRO 90262

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011P000387

Identifier Type: -

Identifier Source: org_study_id