Vascular Aging: The Link That Bridges Age to Atherosclerosis (The VALIDATE Study)

Stopped early

Conditions studied: Atherosclerosis, Cardiovascular Disease, Vascular Diseases

In brief

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. These findings suggest that normal aging alters the vascular substrate so as to promote the development and progression of atherosclerosis. The age-associated changes in vascular structure and function include an increase in central vascular stiffness, intimal proliferation, and endothelial dysfunction. The major hypothesis is that the above alterations in vascular substrate (i.e. vascular age) are an important determinant of the age associated increased likelihood for the development and progression of coronary atherosclerotic disease. This program will non-invasively characterize vascular age and atherosclerotic burden in BLSA participants and individuals with successful aging, i.e. those with no or minimal evidence of coronary atherosclerotic disease, and those with premature, clinically evident coronary artery disease. It will repeat measures of vascular age and atherosclerotic burden 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 two to three-year period, it will test the hypothesis that vascular age is an important determinant of the ageassociated increase in atherosclerotic disease....

Key facts

Study ID

NCT00246493

Run by

National Institute on Aging (NIA)

People needed

495

Starts

2004-06-22

Expected to finish

2017-11-01

Last updated by the study team

2019-12-09

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Atrial fibrillation (due to limitations with gating on MDCT)
• For the first 2 groups: History of procedures used for treatment of CVD (CABG, angioplasty, pacemaker or defibrillator implantation, any surgery on the heart or the arteries)
• Active treatment for cancer
• Serious medical condition which could hinder participation or make it unlikely that they will live for three years (for f/u)
• Weight>300 lb (maximum weight allowed on CT tables)
• Inability to provide an informed consent
• For females, current pregnancy because of the radiation associated with the helical CT and the unknown risks to a fetus. This is only temporary, and women wishing to participate may be enrolled six weeks after delivery.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• National Institute of Aging, Clinical Research Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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