Risk Factors for CV Disease in a Dialysis Cohort

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00006297
First received: September 25, 2000
Last updated: November 10, 2005
Last verified: October 2005
  Purpose

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.


Condition
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Kidney Failure, Chronic

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Longitudinal

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2000
Estimated Study Completion Date: July 2005
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006297

Sponsors and Collaborators
Investigators
Investigator: Josef Coresh Johns Hopkins University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00006297     History of Changes
Other Study ID Numbers: 914
Study First Received: September 25, 2000
Last Updated: November 10, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Kidney Failure, Chronic
Renal Insufficiency
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014