End Stage Renal DiseaseNCT01427374
Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients
An observational study of End Stage Renal Disease, run by University of Alberta at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2011to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Incident hemodialysis and peritoneal dialysis patients
Who may be able to join
- Adults (≥ 18 years of age) commencing hemodialysis or peritoneal dialysis.
Who cannot join
- Unable to provide informed consent.
- CT exclusion criteria
- Pregnancy
- 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).
Show all 15Show fewer
- 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)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Washington
Seattle, Washington, 98195U
About this study
Official title: 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.
Read the 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
- Keywords
- hemodialysis, peritoneal dialysis, chronic kidney disease, cardiovascular risk factors, cardiac imaging, dialysis, parathyroid hormone, vitamin D, coronary artery calcification, left ventricular hypertrophy, genetic predisposition, biochemical markers, infection, pharmacogenomics
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Hypertrophy, Left Ventricular, Genetic Predisposition to Disease, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Artery Calcification
Measured: baseline
Secondary outcomes (5)
Coronary Artery Calcification
Measured: 12 months
Left ventricular mass
Measured: baseline
Left ventricular mass
Measured: 12 months
All cause mortality
Measured: 12 months
Left ventricular hypertrophy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Marcello Tonelli, University of Alberta
- Investigators
- Ravi Thadhani, MD, MPH, Principal investigator, Massachusetts General HospitalMarcello Tonelli, MD, SM, FRCP, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427374
- Sponsor's protocol ID
- 2011P000387
- Other IDs
- IRO 90262
- Status last verified
- Apr 2018
- First submitted
- 30 Aug 2011
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Biochemical and Genetic Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients (CKDCS/LUCID)
- ClinicalTrials.gov ID
- NCT01427374
- Acronym / sponsor ID
- 2011P000387
- Conditions
- End Stage Renal Disease
- Keywords
- hemodialysis, peritoneal dialysis, chronic kidney disease, cardiovascular risk factors, cardiac imaging, dialysis, parathyroid hormone, vitamin D
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- May 2011 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Incident hemodialysis and peritoneal dialysis patients
Key inclusion criteria (1 listed)
- Adults (≥ 18 years of age) commencing hemodialysis or peritoneal dialysis.
Key exclusion criteria (15 listed)
- Unable to provide informed consent.
- CT exclusion criteria
- Pregnancy
- Obesity (>275 lbs)
- Rapid atrial fibrillation, bigeminy or trigeminy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coronary Artery Calcification
Time frame: baseline
5 secondary outcomes
Coronary Artery Calcification
Time frame: 12 months
Left ventricular mass
Time frame: baseline
Left ventricular mass
Time frame: 12 months
All cause mortality
Time frame: 12 months
Left ventricular hypertrophy
Time frame: baseline
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Thadhani, MD, MPH principal investigator
Massachusetts General Hospital
Marcello Tonelli, MD, SM, FRCP principal investigator
University of Alberta
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by University of Alberta at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Artery Calcification (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.