Cardiovascular Diseases Clinical Trial
To determine whether the presence of endothelial dysfunction is an independent risk factor for cardiovascular disease events.
BACKGROUND:
Current research suggests that loss of the vasodilator, anti-thrombotic, and
anti-inflammatory properties of the vascular endothelium plays a dynamic role in the
pathogenesis of cardiovascular disease. Impaired endothelial function, including impaired
nitric oxide-dependent vasodilation is associated with cardiovascular disease risk factors.
Further, there is growing evidence that endothelial function can be improved by risk
modification. However, the available studies have not definitively resolved the issue of the
cross-sectional correlates of endothelial dysfunction because they have been limited to
small samples of highly selected patients. For example, it remains unclear whether
hypercholesterolemia, hypertension, or elevated glucose levels are independent determinants
of endothelial dysfunction. Most importantly, no study has shown a relation between
endothelial dysfunction and increased cardiovascular risk. Such a demonstration would
increase our understanding of the pathogenesis of cardiovascular disease and aid clinicians
in identifying high risk individuals who would benefit most from intervention.
DESIGN NARRATIVE:
Using non-invasive brachial artery ultrasound, endothelial function was examined in about
3,800 men and women of the Framingham Heart Study. The cross-sectional correlates of
endothelial function with known coronary risk factors were examined and cross-sectional
analyses were performed on the relation of endothelial function to prevalent cardiovascular
disease. Observations were made of the adjusted relation of endothelial function to incident
and recurrent cardiovascular events. The central hypothesis was that the presence of
endothelial dysfunction was an independent risk factor for cardiovascular disease events.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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