Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT00246493
Status:
TERMINATED
Last Update Posted:
2019-12-09
First Post:
2005-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Aging: The Link That Bridges Age to Atherosclerosis (The VALIDATE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 495}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-06-22'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11-01', 'completionDateStruct': {'date': '2017-11-01'}, 'lastUpdateSubmitDate': '2019-12-06', 'studyFirstSubmitDate': '2005-10-27', 'studyFirstSubmitQcDate': '2005-10-27', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize vascular age relat-BLSA', 'timeFrame': 'Two-three years'}], 'secondaryOutcomes': [{'measure': 'Characterize vascular age relat-other', 'timeFrame': 'Two-three years'}]}, 'conditionsModule': {'keywords': ['Coronary', 'Endothelial', 'Vascular', 'Atherosclerosis', 'Arterial'], 'conditions': ['Atherosclerosis', 'Cardiovascular Disease', 'Vascular Diseases']}, 'referencesModule': {'references': [{'pmid': '10323658', 'type': 'BACKGROUND', 'citation': 'Lakatta EG. Cardiovascular aging research: the next horizons. J Am Geriatr Soc. 1999 May;47(5):613-25. doi: 10.1111/j.1532-5415.1999.tb02579.x. No abstract available.'}, {'pmid': '11847204', 'type': 'BACKGROUND', 'citation': 'Franklin SS, Wong ND, Larson MG, Kannel WB, Levy D. How important is pulse pressure as a predictor of cardiovascular risk? Hypertension. 2002 Feb;39(2):E12-3. No abstract available.'}, {'pmid': '11473737', 'type': 'BACKGROUND', 'citation': 'Grundy SM. Coronary plaque as a replacement for age as a risk factor in global risk assessment. Am J Cardiol. 2001 Jul 19;88(2A):8E-11E. doi: 10.1016/s0002-9149(01)01712-x.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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....', 'detailedDescription': '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.\n\nThis protocol 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 age-associated increase in atherosclerotic disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nFor all groups:\n\n1. Age 30 years or older\n2. Ability and willingness to participate in the protocol and undergo vascular studies and chest MDCT examinations\n\nFor the second group:\n\n1\\) Coronary artery calcium score of zero or less than 25th percentile of that expected based on age and gender.\n\nFor the third group:\n\n1\\) 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:\n\ni. prior documented myocardial infarction or\n\nii. typical ischemic symptoms and catheterization documented stenosis of greater than or equal to 70% in at least one major coronary artery\n\nIf male, diagnosis was made under 50 years of age\n\nIf female, diagnosis was made under 60 years of age.\n\nEXCLUSION CRITERIA\n\n1. Atrial fibrillation (due to limitations with gating on MDCT)\n2. 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)\n3. Active treatment for cancer\n4. Serious medical condition which could hinder participation or make it unlikely that they will live for three years (for f/u)\n5. Weight\\>300 lb (maximum weight allowed on CT tables)\n6. Inability to provide an informed consent\n7. 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.'}, 'identificationModule': {'nctId': 'NCT00246493', 'briefTitle': 'Vascular Aging: The Link That Bridges Age to Atherosclerosis (The VALIDATE Study)', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Vascular Aging: The Link That Bridges Age to Atherosclerosis (The VALIDATE Study)', 'orgStudyIdInfo': {'id': '999904294'}, 'secondaryIdInfos': [{'id': '04-AG-N294'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institute of Aging, Clinical Research Unit', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Edward G Lakatta, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute on Aging (NIA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}