Vascular Function in the Framingham Third Generation
Primary Purpose
Cardiovascular Diseases, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00035737
First Posted
May 4, 2002
Last Updated
February 20, 2014
Sponsor
Boston University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00035737
Brief Title
Vascular Function in the Framingham Third Generation
Study Type
Observational
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To investigate the role of endothelial dysfunction and increased vascular stiffness as contributors to the pathogenesis of cardiovascular disease.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases
7. Study Design
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emelia Benjamin
Organizational Affiliation
Boston University
12. IPD Sharing Statement
Citations:
PubMed Identifier
15569842
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. doi: 10.1161/01.CIR.0000148821.97162.5E. Epub 2004 Nov 29.
Results Reference
background
PubMed Identifier
14769683
Citation
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. doi: 10.1161/01.CIR.0000112565.60887.1E. Erratum In: Circulation. 2004 Jun 29;109(25):3256.
Results Reference
background
PubMed Identifier
16162617
Citation
Vita JA. Endothelial function and clinical outcome. Heart. 2005 Oct;91(10):1278-9. doi: 10.1136/hrt.2005.061333. No abstract available.
Results Reference
background
PubMed Identifier
14680733
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. doi: 10.1016/j.jacc.2003.09.020. No abstract available.
Results Reference
background
PubMed Identifier
14581383
Citation
Ganz P, Vita JA. Testing endothelial vasomotor function: nitric oxide, a multipotent molecule. Circulation. 2003 Oct 28;108(17):2049-53. doi: 10.1161/01.CIR.0000089507.19675.F9. No abstract available.
Results Reference
background
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Vascular Function in the Framingham Third Generation
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