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Endothelial Vasomotor Function in the Framingham Study

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005751
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: July 2004
  Purpose

To determine whether the presence of endothelial dysfunction is an independent risk factor for cardiovascular disease events.


Condition
Cardiovascular Diseases
Heart Diseases

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: December 1998
Estimated Study Completion Date: November 2003
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005751

Sponsors and Collaborators
Investigators
Investigator: Emilia Benjamin Boston University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005751     History of Changes
Other Study ID Numbers: 5081
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 24, 2014