Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005399
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2000-05-25
Brief Title:
Cohort Study of Heart Rate Variability
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Cohort Study of Heart Rate Variability
Status:
COMPLETED
Status Verified Date:
2016-04
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 examine factors affecting heart rate variability HRV and the role of HRV in heart disease Specifically to examine the role of HRV as a predictor of fatal and nonfatal ischemic heart disease over a six year follow-up of the Atherosclerosis Risk in Communities ARIC population based bi-ethnic cohort on the six year progression of carotid atherosclerosis measured by B-mode ultrasound and on the incidence of hypertension Also to study the effect of elevated fasting insulin glucose diabetes mellitus and other metabolic abnormalities on changes in HRV over nine years of follow-up
Detailed Description:
BACKGROUND
Heart rate variability analysis has been widely used in clinical research as a noninvasive measurement of autonomic function It has been found to be associated with post-myocardial infarction mortality hypertension sudden cardiac death atherosclerosis and diabetes However little epidemiologic research on HRV had been reported prior to this study in 1996 Almost no data were available on the population distribution of HRV its correlates in populations the factors associated with changes in HRV over time or on the cardiovascular sequelae of impaired autonomic function assessed by HRV obtained from population-based prospective studies
DESIGN NARRATIVE
The study was ancillary to ARIC a population-based longitudinal study of cardiovascular and pulmonary diseases The baseline exam was completed in 1987 to 1988 followed by yearly contacts and re-examinations every three years The present study built on the data collected by the ARIC investigators by retrieving and processing beat-to-beat heart rate data collected during the baseline exam Five minutes of beat-to-beat heart rate data were obtained from the ARIC cohort participants during their third follow-up visit Visit 4 in 1996 through 1998 Time and frequency domain HRV indices were derived for an assessment of autonomic function The following HRV indices were computed both for the baseline and the nine-year follow-up exam 1996 through 1998 on the 13000 members of the ARIC cohort time domain indices mean heart rate minimum and maximum heart rate standard deviation of all normal R-R intervals the coefficient of variation of all normal R-R intervals root mean square of the differences of successive R-R intervals and the proportion of adjacent R-R intervals Frequency domain indices were also computed including high frequency power low frequency power and the highlow frequency power ratio
Heart rate variability analysis has been widely used in clinical research as a noninvasive measurement of autonomic function It has been found to be associated with post-myocardial infarction mortality hypertension sudden cardiac death atherosclerosis and diabetes However little epidemiologic research on HRV had been reported prior to this study in 1996 Almost no data were available on the population distribution of HRV its correlates in populations the factors associated with changes in HRV over time or on the cardiovascular sequelae of impaired autonomic function assessed by HRV obtained from population-based prospective studies
DESIGN NARRATIVE
The study was ancillary to ARIC a population-based longitudinal study of cardiovascular and pulmonary diseases The baseline exam was completed in 1987 to 1988 followed by yearly contacts and re-examinations every three years The present study built on the data collected by the ARIC investigators by retrieving and processing beat-to-beat heart rate data collected during the baseline exam Five minutes of beat-to-beat heart rate data were obtained from the ARIC cohort participants during their third follow-up visit Visit 4 in 1996 through 1998 Time and frequency domain HRV indices were derived for an assessment of autonomic function The following HRV indices were computed both for the baseline and the nine-year follow-up exam 1996 through 1998 on the 13000 members of the ARIC cohort time domain indices mean heart rate minimum and maximum heart rate standard deviation of all normal R-R intervals the coefficient of variation of all normal R-R intervals root mean square of the differences of successive R-R intervals and the proportion of adjacent R-R intervals Frequency domain indices were also computed including high frequency power low frequency power and the highlow frequency power ratio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4313 | OTHER | NHLBI | httpsreporternihgovquickSearchR01HL055669 |
| R01HL055669 | NIH | None | None |