Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006297
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-09-25
Brief Title:
Risk Factors for CV Disease in a Dialysis Cohort
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 ie 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 Lpa levels and apoa 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 24 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 123612824 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
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 ie 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 Lpa levels and apoa 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 24 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 123612824 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL062985 | NIH | None | httpsreporternihgovquickSearchR01HL062985 |