Vascular Function in the Framingham Third Generation

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035737
• Other study ID #: 1050
• Secondary ID: R01HL070100
• Status: Completed
• Phase: N/A
• First received: May 4, 2002
• Last updated: February 20, 2014
• Start date: May 2002
• Est. completion date: March 2007

Study information

• Verified date: February 2014
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To investigate the role of endothelial dysfunction and increased vascular stiffness as contributors to the pathogenesis of cardiovascular disease.

Description:

BACKGROUND:

Increasingly, researchers understand that endothelial dysfunction and increased vascular stiffness contribute to the pathogenesis of cardiovascular disease (CVD). The Framingham Heart Study (FHS) has been examining vascular function in about 3600 middle-aged and elderly participants of the FHS Offspring and minority OMNI cohorts.

DESIGN NARRATIVE:

The study characterizes vascular function by performing noninvasive studies of endothelial function with brachial ultrasound flow-mediated dilation, and of vascular stiffness with arterial tonometry, in 3850 adult offspring of the FHS Offspring and OMNI cohorts. The total of over 7000 vascular examinations in an extensively studied multi-generational community-based cohort provides the opportunity to characterize the environmental and genetic determinants, and the prognosis of altered vascular function. The study hypotheses are: vascular function is determined by both environmental and genetic factors; endothelial function and vascular stiffness phenotypes are associated with each other: and vascular dysfunction predisposes to the development of hypertension (HTN) and cardiovascular disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (5)

Benjamin EJ, Larson MG, Keyes MJ, Mitchell GF, Vasan RS, Keaney JF Jr, Lehman BT, Fan S, Osypiuk E, Vita JA. Clinical correlates and heritability of flow-mediated dilation in the community: the Framingham Heart Study. Circulation. 2004 Feb 10;109(5):613-9. Erratum in: Circulation. 2004 Jun 29;109(25):3256. — View Citation

Ganz P, Vita JA. Testing endothelial vasomotor function: nitric oxide, a multipotent molecule. Circulation. 2003 Oct 28;108(17):2049-53. Review. — View Citation

Vita JA, Keaney JF Jr, Larson MG, Keyes MJ, Massaro JM, Lipinska I, Lehman BT, Fan S, Osypiuk E, Wilson PW, Vasan RS, Mitchell GF, Benjamin EJ. Brachial artery vasodilator function and systemic inflammation in the Framingham Offspring Study. Circulation. 2004 Dec 7;110(23):3604-9. Epub 2004 Nov 29. — View Citation

Vita JA, Mitchell GF. Effects of shear stress and flow pulsatility on endothelial function: insights gleaned from external counterpulsation therapy. J Am Coll Cardiol. 2003 Dec 17;42(12):2096-8. — View Citation

Vita JA. Endothelial function and clinical outcome. Heart. 2005 Oct;91(10):1278-9. Review. — View Citation