Status:
TERMINATED
Vascular Aging: The Link That Bridges Age to Atherosclerosis (The VALIDATE Study)
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Atherosclerosis
Cardiovascular Disease
Eligibility:
All Genders
30+ years
Brief Summary
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 clinica...
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 clinica...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- For all groups:
- Age 30 years or older
- Ability and willingness to participate in the protocol and undergo vascular studies and chest MDCT examinations
- For the second group:
- 1\) Coronary artery calcium score of zero or less than 25th percentile of that expected based on age and gender.
- For the third group:
- 1\) Coronary artery calcium score which is greater than the 50th percentile of that computed based on age and gender, or known coronary disease on the basis of:
- i. prior documented myocardial infarction or
- ii. typical ischemic symptoms and catheterization documented stenosis of greater than or equal to 70% in at least one major coronary artery
- If male, diagnosis was made under 50 years of age
- If female, diagnosis was made under 60 years of age.
- EXCLUSION CRITERIA
- 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.
Exclusion
Key Trial Info
Start Date :
June 22 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT00246493
Start Date
June 22 2004
End Date
November 1 2017
Last Update
December 9 2019
Active Locations (2)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
2
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224