Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005756
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2000-05-25
Brief Title:
Epidemiology of Coronary Calcification in the Elderly
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the prevalence and prognostic value of subclinical atherosclerosis in the Pittsburgh SHEP cohort and a cohort of normal controls
Detailed Description:
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 US population
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 US population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL064587 | NIH | None | httpsreporternihgovquickSearchR01HL064587 |