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| Descriptive Information Fields | |||||
| Brief Title † | The VALIDATE Study: Vascular Aging - The Link That Bridges Age to Atherosclerosis | ||||
| Official Title † | Vascular Aging: The Link That Bridges Age to Atherosclerosis | ||||
| Brief Summary | The purpose of this study is to examine why age is a strong risk factor for developing atherosclerosis, and whether this may, in part, be due to the effects of age on blood vessels. |
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| Detailed Description | The prevalence, incidence, and severity of atherosclerotic disease all markedly increase with age. Basic experimental and observational data demonstrate that aging magnifies the pathologic and clinical consequences of established risk factors and is the most potent individual risk factor for coronary atherosclerosis and for adverse outcomes following an ischemic event (such as stroke). These findings suggest that normal aging alters the vascular substrate so as to promote the development and progression of atherosclerosis. This study will non-invasively characterize vascular age and atherosclerotic burden in participants with "successful" aging (i.e. those with no or minimal evidence of coronary atherosclerotic disease), and those with premature, clinically evident coronary artery disease. Measures of vascular age and atherosclerotic burden will be repeated three years after the first assessment. By examining the impact of vascular age on the initial extent and the progression of atherosclerotic burden over a three-year period, the study will test the hypothesis that vascular age is an important determinant of the age associated increase in atherosclerotic disease. Three groups of participants will be studied: Group 1: Participants in the Baltimore Longitudinal Study of Aging (BLSA) without known coronary artery disease. The anticipated number is 330. Group 2: Individuals outside of the BLSA without known coronary, cerebral, and peripheral artery disease and with coronary artery calcium scores on MDCT (Multislice Detector Computed Tomography) of zero or less than the 25th percentile expected based on their gender and age. The anticipated number is 60. Group 3: Individuals outside of the BLSA with premature coronary disease defined as prior documented myocardial infarction or symptoms compatible with ischemia in association with catheterization documented coronary disease of > 70% in a major coronary artery in a man younger than 50 years or a woman younger than 60 years. The anticipated number is 60. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Case Control, Prospective | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Atherosclerosis | ||||
| Intervention † | |||||
| MEDLINE PMIDs | 16103272, 10323658, 8403292, 9603539, 9603549 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 450 | ||||
| Start Date † | June 2004 | ||||
| Completion Date | December 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria: For all groups:
Group 2:
Group 3:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00246493 | ||||
| Organization ID | AG0054 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | October 27, 2005 | ||||
| Last Updated Date | August 19, 2008 | ||||