Cardiovascular DiseasesNCT00006297
Risk Factors for CV Disease in a Dialysis Cohort
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate whether traditional risk factors and novel risk factors predict higher risk of atherosclerotic cardiovascular disease (ASCVD) in a prospective study of incident dialysis patients. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Atherosclerosis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2000to Jul 2005
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate whether traditional risk factors and novel risk factors predict higher risk of atherosclerotic cardiovascular disease (ASCVD) in a prospective study of incident dialysis patients.
Read the detailed description
BACKGROUND:
There is a very high mortality especially from cardiovascular disease among patients who are on dialysis. Atherosclerotic cardiovascular disease (ASCVD) is a leading contributor to the high morbidity and mortality among end-stage renal disease (ESRD) patients, accounting for 36 percent of ESRD deaths (total annual mortality of 23 percent). The high mortality among dialysis patients is a major public health problem and the ability to identify and treat risk factors that may reduce morbidity and mortality would be of substantial benefit. There are well-known risk factors for cardiovascular disease that certainly are related to morbidity and mortality among dialysis patients, i.e., relationship to hypertension, diabetes, smoking, etc. However, some of the new risk factors could also contribute to the excess mortality.
DESIGN NARRATIVE:
The prospective study tested the hypothesis that higher levels of several novel risk factors (Lp(a) levels and apo(a) isoforms; homocysteine and related vitamins; Chlamydia pneumoniae and cytomegalovirus; and C-reactive protein and fibrinogen) and traditional risk factors predicted higher risk of ASCVD in 925 incident dialysis patients recruited within three months of starting dialysis. Although these factors had been implicated in the etiology of ASCVD in ESRD patients, little prospective data existed. The cohort had already been recruited through a collaboration between Johns Hopkins and 80 Dialysis Clinics Incorporated (DCI) clinics; many of the important predictors and possible confounders had been measured. Long-term follow-up was obtained by extending mean followup of 2.4 years by four more years.
The investigators 1) extended specimen collection, and follow-up, and instituted standardized review of ASCVD events; 2) characterized baseline associations of novel and traditional factors with each other, dialysis modality and dose, nutritional status, and ASCVD prevalence in the full cohort using a cross-sectional design; 3) determined whether baseline levels of risk factors predicted subsequent incidence of ASCVD events, and total mortality using a prospective cohort study design and tested a priori hypothesized interactions between risk factors and the risk of ASCVD; 4) studied the variability of risk factors over time using annual measurements in a random subset of 180 patients (subcohort) using a longitudinal design; and lastly, 5) used a case-cohort design, utilizing the subcohort, to test whether the most recent level before an ASCVD event, the baseline level, or the mean level of each risk factor was most predictive of ASCVD risk. Baseline data collection included a patient health questionnaire and a standardized review of comorbidity using dialysis chart records. Serum, plasma and DNA were stored at -80 degrees C. from patient visits at recruitment (month 0), and followup (months 1,2,3,6,12,8,24, etc.). ASCVD was assessed by review of hospital charts, patients and care providers questionnaires, and HCFA death forms.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Atherosclerosis, Kidney Failure, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2000 (estimated)
- Study startSep 2000
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Josef Coresh, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006297
- Sponsor's protocol ID
- 914
- Other IDs
- R01HL062985
- Status last verified
- Oct 2005
- First submitted
- 25 Sep 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Miskulin DC, Meyer KB, Martin AA, Fink NE, Coresh J, Powe NR, Klag MJ, Levey AS; Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. Comorbidity and its change predict survival in incident dialysis patients. Am J Kidney Dis. 2003 Jan;41(1):149-61. doi: 10.1053/ajkd.2003.50034.
PubMed 12500232Astor BC, Eustace JA, Klag MJ, Powe NR, Longenecker JC, Fink NE, Marcovina SM, Coresh J; CHOICE Study. Race-specific association of lipoprotein(a) with vascular access interventions in hemodialysis patients: the CHOICE Study. Kidney Int. 2002 Mar;61(3):1115-23. doi: 10.1046/j.1523-1755.2002.00194.x.
PubMed 11849466Astor BC, Eustace JA, Powe NR, Klag MJ, Sadler JH, Fink NE, Coresh J. Timing of nephrologist referral and arteriovenous access use: the CHOICE Study. Am J Kidney Dis. 2001 Sep;38(3):494-501. doi: 10.1053/ajkd.2001.26833.
PubMed 11532680Liu Y, Coresh J, Eustace JA, Longenecker JC, Jaar B, Fink NE, Tracy RP, Powe NR, Klag MJ. Association between cholesterol level and mortality in dialysis patients: role of inflammation and malnutrition. JAMA. 2004 Jan 28;291(4):451-9. doi: 10.1001/jama.291.4.451.
PubMed 14747502Plantinga LC, Fink NE, Sadler JH, Levey AS, Levin NW, Rubin HR, Coresh J, Klag MJ, Powe NR. Frequency of patient-physician contact and patient outcomes in hemodialysis care. J Am Soc Nephrol. 2004 Jan;15(1):210-8. doi: 10.1097/01.asn.0000106101.48237.9d.
PubMed 14694175Longenecker JC, Coresh J, Marcovina SM, Powe NR, Levey AS, Giaculli F, Fink NE, Klag MJ. Lipoprotein(a) and prevalent cardiovascular disease in a dialysis population: The Choices for Healthy Outcomes in Caring for ESRD (CHOICE) study. Am J Kidney Dis. 2003 Jul;42(1):108-16. doi: 10.1016/s0272-6386(03)00413-x.
PubMed 12830462Fox CS, Longenecker JC, Powe NR, Klag MJ, Fink NE, Parekh R, Coresh J; CHOICE Study. Undertreatment of hyperlipidemia in a cohort of United States kidney dialysis patients. Clin Nephrol. 2004 May;61(5):299-307. doi: 10.5414/cnp61299.
PubMed 15182124Unruh ML, Levey AS, D'Ambrosio C, Fink NE, Powe NR, Meyer KB; Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. Restless legs symptoms among incident dialysis patients: association with lower quality of life and shorter survival. Am J Kidney Dis. 2004 May;43(5):900-9. doi: 10.1053/j.ajkd.2004.01.013.
PubMed 15112181Plantinga LC, Fink NE, Jaar BG, Sadler JH, Coresh J, Klag MJ, Levey AS, Powe NR. Frequency of sit-down patient care rounds, attainment of clinical performance targets, hospitalization, and mortality in hemodialysis patients. J Am Soc Nephrol. 2004 Dec;15(12):3144-53. doi: 10.1097/01.ASN.0000146424.91128.2A.
PubMed 15579518Jaar BG, Coresh J, Plantinga LC, Fink NE, Klag MJ, Levey AS, Levin NW, Sadler JH, Kliger A, Powe NR. Comparing the risk for death with peritoneal dialysis and hemodialysis in a national cohort of patients with chronic kidney disease. Ann Intern Med. 2005 Aug 2;143(3):174-83. doi: 10.7326/0003-4819-143-3-200508020-00003.
PubMed 16061915Liu Y, Berthier-Schaad Y, Fink NE, Fallin MD, Tracy RP, Klag MJ, Smith MW, Coresh J. Beta-fibrinogen haplotypes and the risk for cardiovascular disease in a dialysis cohort. Am J Kidney Dis. 2005 Jul;46(1):78-85. doi: 10.1053/j.ajkd.2005.03.008.
PubMed 15983960Longenecker JC, Klag MJ, Marcovina SM, Liu YM, Jaar BG, Powe NR, Fink NE, Levey AS, Coresh J. High lipoprotein(a) levels and small apolipoprotein(a) size prospectively predict cardiovascular events in dialysis patients. J Am Soc Nephrol. 2005 Jun;16(6):1794-802. doi: 10.1681/ASN.2004110922. Epub 2005 Mar 30.
PubMed 15800123Astor BC, Eustace JA, Powe NR, Klag MJ, Fink NE, Coresh J; CHOICE Study. Type of vascular access and survival among incident hemodialysis patients: the Choices for Healthy Outcomes in Caring for ESRD (CHOICE) Study. J Am Soc Nephrol. 2005 May;16(5):1449-55. doi: 10.1681/ASN.2004090748. Epub 2005 Mar 23.
PubMed 15788468Plantinga LC, Jaar BG, Fink NE, Sadler JH, Levin NW, Coresh J, Klag MJ, Powe NR. Frequency of patient-physician contact in chronic kidney disease care and achievement of clinical performance targets. Int J Qual Health Care. 2005 Apr;17(2):115-21. doi: 10.1093/intqhc/mzi010. Epub 2005 Feb 21.
PubMed 15723821
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for CV Disease in a Dialysis Cohort
- ClinicalTrials.gov ID
- NCT00006297
- Acronym / sponsor ID
- 914
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2000
- Study completion
- Jul 2005 (actual)
- First posted
- 26 Sep 2000 (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.
To investigate whether traditional risk factors and novel risk factors predict higher risk of atherosclerotic cardiovascular disease (ASCVD) in a prospective study of incident dialysis patients.
Detailed description
BACKGROUND:
There is a very high mortality especially from cardiovascular disease among patients who are on dialysis. Atherosclerotic cardiovascular disease (ASCVD) is a leading contributor to the high morbidity and mortality among end-stage renal disease (ESRD) patients, accounting for 36 percent of ESRD deaths (total annual mortality of 23 percent). The high mortality among dialysis patients is a major public health problem and the ability to identify and treat risk factors that may reduce morbidity and mortality would be of substantial benefit. There are well-known risk factors for cardiovascular disease that certainly are related to morbidity and mortality among dialysis patients, i.e., relationship to hypertension, diabetes, smoking, etc. However, some of the new risk factors could also contribute to the excess mortality.
DESIGN NARRATIVE:
The prospective study tested the hypothesis that higher levels of several novel risk factors (Lp(a) levels and apo(a) isoforms; homocysteine and related vitamins; Chlamydia pneumoniae and cytomegalovirus; and C-reactive protein and fibrinogen) and traditional risk factors predicted higher risk of ASCVD in 925 incident dialysis patients recruited within three months of starting dialysis. Although these factors had been implicated in the etiology of ASCVD in ESRD patients, little prospective data existed. The cohort had already been recruited through a collaboration between Johns Hopkins and 80 Dialysis Clinics Incorporated (DCI) clinics; many of the important predictors and possible confounders had been measured. Long-term follow-up was obtained by extending mean followup of 2.4 years by four more years.
The investigators 1) extended specimen collection, and follow-up, and instituted standardized review of ASCVD events; 2) characterized baseline associations of novel and traditional factors with each other, dialysis modality and dose, nutritional status, and ASCVD prevalence in the full cohort using a cross-sectional design; 3) determined whether baseline levels of risk factors predicted subsequent incidence of ASCVD events, and total mortality using a prospective cohort study design and tested a priori hypothesized interactions between risk factors and the risk of ASCVD; 4) studied the variability of risk factors over time using annual measurements in a random subset of 180 patients (subcohort) using a longitudinal design; and lastly, 5) used a case-cohort design, utilizing the subcohort, to test whether the most recent level before an ASCVD event, the baseline level, or the mean level of each risk factor was most predictive of ASCVD risk. Baseline data collection included a patient health questionnaire and a standardized review of comorbidity using dialysis chart records. Serum, plasma and DNA were stored at -80 degrees C. from patient visits at recruitment (month 0), and followup (months 1,2,3,6,12,8,24, etc.). ASCVD was assessed by review of hospital charts, patients and care providers questionnaires, and HCFA death forms.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 12500232Miskulin DC, Meyer KB, Martin AA, Fink NE, Coresh J, Powe NR, Klag MJ, Levey AS; Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. Comorbidity and its change predict survival in incident dialysis patients. Am J Kidney Dis. 2003 Jan;41(1):149-61. doi: 10.1053/ajkd.2003.50034.
- Background: PubMed 11849466Astor BC, Eustace JA, Klag MJ, Powe NR, Longenecker JC, Fink NE, Marcovina SM, Coresh J; CHOICE Study. Race-specific association of lipoprotein(a) with vascular access interventions in hemodialysis patients: the CHOICE Study. Kidney Int. 2002 Mar;61(3):1115-23. doi: 10.1046/j.1523-1755.2002.00194.x.
- Background: PubMed 11532680Astor BC, Eustace JA, Powe NR, Klag MJ, Sadler JH, Fink NE, Coresh J. Timing of nephrologist referral and arteriovenous access use: the CHOICE Study. Am J Kidney Dis. 2001 Sep;38(3):494-501. doi: 10.1053/ajkd.2001.26833.
- Background: PubMed 14747502Liu Y, Coresh J, Eustace JA, Longenecker JC, Jaar B, Fink NE, Tracy RP, Powe NR, Klag MJ. Association between cholesterol level and mortality in dialysis patients: role of inflammation and malnutrition. JAMA. 2004 Jan 28;291(4):451-9. doi: 10.1001/jama.291.4.451.
- Background: PubMed 14694175Plantinga LC, Fink NE, Sadler JH, Levey AS, Levin NW, Rubin HR, Coresh J, Klag MJ, Powe NR. Frequency of patient-physician contact and patient outcomes in hemodialysis care. J Am Soc Nephrol. 2004 Jan;15(1):210-8. doi: 10.1097/01.asn.0000106101.48237.9d.
- Background: PubMed 12830462Longenecker JC, Coresh J, Marcovina SM, Powe NR, Levey AS, Giaculli F, Fink NE, Klag MJ. Lipoprotein(a) and prevalent cardiovascular disease in a dialysis population: The Choices for Healthy Outcomes in Caring for ESRD (CHOICE) study. Am J Kidney Dis. 2003 Jul;42(1):108-16. doi: 10.1016/s0272-6386(03)00413-x.
- Background: PubMed 15182124Fox CS, Longenecker JC, Powe NR, Klag MJ, Fink NE, Parekh R, Coresh J; CHOICE Study. Undertreatment of hyperlipidemia in a cohort of United States kidney dialysis patients. Clin Nephrol. 2004 May;61(5):299-307. doi: 10.5414/cnp61299.
- Background: PubMed 15112181Unruh ML, Levey AS, D'Ambrosio C, Fink NE, Powe NR, Meyer KB; Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. Restless legs symptoms among incident dialysis patients: association with lower quality of life and shorter survival. Am J Kidney Dis. 2004 May;43(5):900-9. doi: 10.1053/j.ajkd.2004.01.013.
- Background: PubMed 15579518Plantinga LC, Fink NE, Jaar BG, Sadler JH, Coresh J, Klag MJ, Levey AS, Powe NR. Frequency of sit-down patient care rounds, attainment of clinical performance targets, hospitalization, and mortality in hemodialysis patients. J Am Soc Nephrol. 2004 Dec;15(12):3144-53. doi: 10.1097/01.ASN.0000146424.91128.2A.
- Background: PubMed 16061915Jaar BG, Coresh J, Plantinga LC, Fink NE, Klag MJ, Levey AS, Levin NW, Sadler JH, Kliger A, Powe NR. Comparing the risk for death with peritoneal dialysis and hemodialysis in a national cohort of patients with chronic kidney disease. Ann Intern Med. 2005 Aug 2;143(3):174-83. doi: 10.7326/0003-4819-143-3-200508020-00003.
- Background: PubMed 15983960Liu Y, Berthier-Schaad Y, Fink NE, Fallin MD, Tracy RP, Klag MJ, Smith MW, Coresh J. Beta-fibrinogen haplotypes and the risk for cardiovascular disease in a dialysis cohort. Am J Kidney Dis. 2005 Jul;46(1):78-85. doi: 10.1053/j.ajkd.2005.03.008.
- Background: PubMed 15800123Longenecker JC, Klag MJ, Marcovina SM, Liu YM, Jaar BG, Powe NR, Fink NE, Levey AS, Coresh J. High lipoprotein(a) levels and small apolipoprotein(a) size prospectively predict cardiovascular events in dialysis patients. J Am Soc Nephrol. 2005 Jun;16(6):1794-802. doi: 10.1681/ASN.2004110922. Epub 2005 Mar 30.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Josef Coresh
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006297, which also lists 14 linked publications.
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 18 Feb 2016.