An observational study in Cardiovascular Diseases, Heart Diseases and Coronary Arteriosclerosis, sponsored by University of Pittsburgh. Completed. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-01-13.
Sponsored by University of Pittsburgh · Observational
To investigate the prevalence and prognostic value of subclinical atherosclerosis in the Pittsburgh SHEP cohort and a cohort of normal controls.
BACKGROUND:
This is an ancillary study to the Systolic Hypertension in the Elderly Program (SHEP)
DESIGN NARRATIVE:
Continued annual telephone follow-up of the remaining 178 Pittsburgh SHEP participants and 168 controls will be conducted . A final clinic visit will include measures of coronary and aortic calcification using electron beam computed tomography (CT), pulse wave velocity as a measure of aortic stiffening and cognitive function testing. For the Pittsburgh SHEP cohort, the antihypertensive treatment effect has been striking with event rates for the active and placebo groups continuing to diverge beyong the end of SHEP. Successful demonstration of a treatment effect on coronary calcium scores would be the first randomized data showing an antihypertensive effect directly in the coronary arteries. Risk factors for coronary calcification will be evaluated, producing data of a type not yet available in the literature for older adults and not being collected in any other ongoing studies of the elderly. The added measures of vascular stiffness will supplement the extensive data on subclinical atherosclerosis already available for this cohort. The extent to which these measures predict cardiovascular events will be evaluated. The study has been renewed through July 2006.
Since hypertension and aging are associated with cognitive impairment and vascular dementia, SHEP participants assigned to the placebo group are expected to have lower cognitive function compared to those assigned to active treatment. Among both hypertensive and normotensive groups, lower cognitive function among those with evidence of subclinical atherosclerosis is expected.
Finally, members of the cohort who were originally normotensive at study entry are now developing systolic hypertension. These subjects will allow a prospective evaluation of risk factors for systolic hypertension. Continued study of this cohort into their 80s will provide unique data on the risks and etiology of systolic hypertension, the efficacy of its treatment and the prognostic value of a number of measures of subclinical atherosclerosis. It is predicted that the results will be directly applicable to the largest growing segment of the U.S. population.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
Browse Cardiovascular Diseases studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
614 older adults aged, on average, 80 years (range, 67 to 99 years); 367 (60%) were women, and 143 (23%) were black.
Participating in the Cardiovascular Health Study (CHS) at the University of Pittsburgh Site.
Inclusion criteria:
Age 65 or older in 1989-90 Able to give informed consent Able to travel to study site No plans to move from the area within 3 years of CHS enrollment
Exclusion criteria:
Inability to give informed consent at time of EBCT scan Unable to travel to study center Lives in nursing home.
No study locations are listed for this record.
Plan to share: Yes
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh