Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00149435 |
| Other study ID # |
1295 |
| Secondary ID |
5R01HL080295-07 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2005 |
| Est. completion date |
May 2009 |
Study information
| Verified date |
May 2018 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
