Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00078429 |
| Other study ID # |
1221 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
February 25, 2004 |
| Last updated |
July 23, 2008 |
| Start date |
July 2003 |
| Est. completion date |
June 2008 |
Study information
| Verified date |
July 2008 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To investigation the association of thrombosis and inflammation genes with sub-clinical
cardiovascular disease and with incident myocardial infarction and stroke in older adults.
Description:
DESIGN NARRATIVE:
The study represents a collaborative effort among investigators of the Cardiovascular Health
Research Unit, Department of Genome Sciences at the University of Washington (UW), and the
multi-center Cardiovascular Health Study (CHS), including the CHS Blood Laboratory at the
University of Vermont. The study links advances in thrombosis and inflammation biology,
large-scale human genomics, and population and statistical genetics, with the unique
resources of CHS, a large, bi-racial cohort of older adults. In older men and women without
clinically apparent vascular disease, carotid intimal-medial thickness or IMT (a measure of
subclinical atherosclerosis), C-reactive protein (a sensitive marker of inflammation), and
D-dimer (a global marker of activation of the hemostatic system) predict subsequent clinical
events such as myocardial infarction (MI) and stroke. While the therapeutic benefits of
thrombolytic therapy and aspirin suggest a major role for clotting and inflammation in the
etiology of coronary disease and stroke, the genetic determinants of these risk factors,
which are also influenced by traditional lifestyle risk factors such as smoking and obesity,
remain largely unexplored in older adults. The setting for this study is the Cardiovascular
Health Study, a cohort study of 5888 older adults designed to assess risk factors for stroke
and coronary disease. Data on traditional risk factors, on measures of subclinical disease,
and cardiovascular events are available to the ancillary study. By integrating recent
clinical and experimental data on age-related and vascular bed-specific regulation of blood
coagulation, and incorporating complete human genomic DNA sequence variation data from the
NHLBI-funded UW Program for Genomic Applications, the investigators will evaluate thoroughly
the association of thrombosis and inflammation genes with (1) carotid IMT, CRP, and D-dimer
levels measured at baseline and (2) incident MI and stroke in adults >65 years old followed
for up to 12 years.
