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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00246493
First received: October 27, 2005
Last updated: March 14, 2014
Last verified: September 2013
  Purpose

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.


Condition
Atherosclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Vascular Aging: The Link That Bridges Age to Atherosclerosis (The VALIDATE Study)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 510
Study Start Date: June 2004
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. 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

For all groups:

  1. Age 30 years or older
  2. 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

  1. Atrial fibrillation (due to limitations with gating on MDCT)
  2. 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)
  3. Active treatment for cancer
  4. Serious medical condition which could hinder participation or make it unlikely that they will live for three years (for f/u)
  5. Weight> 300 lb (maximum weight allowed on CT tables)
  6. Inability to provide an informed consent
  7. For females, current pregnancy because of the radiation associated with the helical CT, and the unknown risks to a fetus associated with MRI. This is only temporary, and women wishing to participate may be enrolled six weeks after delivery.
  8. Subjects who decline MRI or with contraindications to MRI scanning, (e.g. aneurysm clip, pacemaker, metallic prosthesis, or foreign body), or on whom MRI can not be performed due to logistical reasons will not be excluded from the study but will not undergo the MRI study.
  9. Subejcts with contraindications to gadolinium contrast agent (i.e., history of anaphylaxis) will not be excluded from the study but will not undergo the MRI study.
  10. Subjects with renal insufficiency (creatinine clearance less than 60 ml/min/1.73m(2) will not be excluded from the study but will not undergo the MRI study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246493

Locations
United States, Maryland
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Investigators
Principal Investigator: Edward G Lakatta, M.D. National Institute on Aging (NIA)
  More Information

No publications provided

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT00246493     History of Changes
Other Study ID Numbers: 999904294, 04-AG-N294
Study First Received: October 27, 2005
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Coronary
Endothelial
Vascular
Atherosclerosis
Arterial

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014