Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-25 @ 7:47 PM
Study NCT ID:
NCT00149435
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiovascular Health Study (CHS) Events Follow-up Study
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2018-05
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 support follow-up for the Cardiovascular Health Study (CHS) of coronary heart disease and stroke risk factors in adults 65 years or older.
Detailed Description:
BACKGROUND:
The Cardiovascular Health Study (CHS) is an NHLBI-funded cohort study of risk factors for coronary heart disease (CHD) and stroke in adults 65 years or older. In the early 1990s, 5888 participants underwent examinations that included traditional risk factors and measures of sub-clinical disease. During follow-up, many exam components were repeated, and CVD events were ascertained. The National Heart, Lung, and Blood Institute has extended CHS contract funding (1) to implement a model for a transition from contract-funding to investigator-initiated research and (2) to enhance access to CHS data for future papers and ancillary studies by CHS and non-CHS colleagues. The Events Follow-up Study will provide a foundation for the transition. Current and future papers and ancillary studies using CHS data or stored specimens will have additional power and can be conducted more efficiently if a service events-core continues to collect and adjudicate CVD events and deaths in a standardized fashion.
DESIGN NARRATIVE:
Structurally, the primary aims are: (1) to evaluate the incidence rates of and risk factors for CVD in older adults, including comparisons between blacks and whites, men and women, young old and old; (2) the evaluation of prognosis in inception cohorts of older adults with new-onset conditions such as heart failure (HF) and atrial fibrillation; and (3) the evaluation of associations between risk-factor change and the incidence of subsequent events. Questions of interest include: What are the determinants of the low CHD incidence in women 80 yrs and older? Do older black women also have a low CHD incidence? What are the determinants of CHD, HF, and stroke in adults 80 and older? Are risk factors different between men and women, whites and blacks? Do traditional risk factors and measures of sub-clinical disease continue to be powerful predictors of CHD, HF and stroke in those 80 and older? In this study, the investigators expect to make over 20,000 phone calls to identify 6000 hospitalizations, 1000 deaths, 3000 events for detailed review, and 1500 new events, including 370 CHD, 300 stroke, and 450 HF. These new events represent an increase in the number of CVD events of 29% to 35% in whites and an increase of 40% to 49% in blacks. The data and specimens collected in CHS represent a major national resource for the study of health, aging, and cardiovascular disease in older adults. Additional events follow-up will not only provide the opportunity to address the aims of this study, but also enhance the power of current and future CHS papers and ancillary studies by CHS and non-CHS colleagues.
The Cardiovascular Health Study (CHS) is an NHLBI-funded cohort study of risk factors for coronary heart disease (CHD) and stroke in adults 65 years or older. In the early 1990s, 5888 participants underwent examinations that included traditional risk factors and measures of sub-clinical disease. During follow-up, many exam components were repeated, and CVD events were ascertained. The National Heart, Lung, and Blood Institute has extended CHS contract funding (1) to implement a model for a transition from contract-funding to investigator-initiated research and (2) to enhance access to CHS data for future papers and ancillary studies by CHS and non-CHS colleagues. The Events Follow-up Study will provide a foundation for the transition. Current and future papers and ancillary studies using CHS data or stored specimens will have additional power and can be conducted more efficiently if a service events-core continues to collect and adjudicate CVD events and deaths in a standardized fashion.
DESIGN NARRATIVE:
Structurally, the primary aims are: (1) to evaluate the incidence rates of and risk factors for CVD in older adults, including comparisons between blacks and whites, men and women, young old and old; (2) the evaluation of prognosis in inception cohorts of older adults with new-onset conditions such as heart failure (HF) and atrial fibrillation; and (3) the evaluation of associations between risk-factor change and the incidence of subsequent events. Questions of interest include: What are the determinants of the low CHD incidence in women 80 yrs and older? Do older black women also have a low CHD incidence? What are the determinants of CHD, HF, and stroke in adults 80 and older? Are risk factors different between men and women, whites and blacks? Do traditional risk factors and measures of sub-clinical disease continue to be powerful predictors of CHD, HF and stroke in those 80 and older? In this study, the investigators expect to make over 20,000 phone calls to identify 6000 hospitalizations, 1000 deaths, 3000 events for detailed review, and 1500 new events, including 370 CHD, 300 stroke, and 450 HF. These new events represent an increase in the number of CVD events of 29% to 35% in whites and an increase of 40% to 49% in blacks. The data and specimens collected in CHS represent a major national resource for the study of health, aging, and cardiovascular disease in older adults. Additional events follow-up will not only provide the opportunity to address the aims of this study, but also enhance the power of current and future CHS papers and ancillary studies by CHS and non-CHS colleagues.
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R01HL080295-07 | NIH | None | https://reporter.nih.gov/quic… | View |