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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00246493 |
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.
Condition |
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Atherosclerosis |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Vascular Aging: The Link That Bridges Age to Atherosclerosis |
whole blood and urine
Estimated Enrollment: | 450 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Baltimore Longitudinal Study of Aging, NIA participants
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Individuals without known coronary, cerebral, and peripheral artery disease and with coronary artery calcium scores on MDCT of zero or less than the 25th percentile expected based on their gender and age
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3
Individuals who on a screening MDCT scan have a coronary artery calcium score which is greater than the 50th percentile for their age and gender or individuals with premature coronary disease defined as prior documented myocardial infarction or symptoms compatible with ischemia in association with catheterization documented coronary disease of > 70%
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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.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Community sample
Inclusion Criteria:
For all groups:
Group 2:
Group 3:
Exclusion Criteria:
Contact: Samer Najjar, MD | 410-350-3932 | najjarsa@grc.nia.nih.gov |
United States, Maryland | |
NIA Clinical Research Unit at Harbor Hospital | Recruiting |
Baltimore, Maryland, United States, 21225 | |
Contact: NIA Recruiter 410-350-3941 NIAStudiesRecruitment@mail.nih.gov |
Principal Investigator: | Samer S. Najjar, MD | National Institute on Aging, National Institutes of Health |
Responsible Party: | National Institute of Aging ( Samer Najjar, MD, Principle Investigator ) |
Study ID Numbers: | AG0054 |
Study First Received: | October 27, 2005 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00246493 |
Health Authority: | United States: Federal Government |
intimal proliferation endothelial dysfunction atherosclerosis vascular aging Arterial aging |
Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Arteriosclerosis |
Cardiovascular Diseases |