Epidemiology of Coronary Calcification in the Elderly

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005756
• Other study ID #: 5111
• Secondary ID: R01HL064587
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: January 12, 2016
• Start date: August 1999
• Est. completion date: July 2007

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To investigate the prevalence and prognostic value of subclinical atherosclerosis in the Pittsburgh SHEP cohort and a cohort of normal controls.

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 U.S. population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 100 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypertension
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (5)

Newman AB, Naydeck BL, Sutton-Tyrrell K, Edmundowicz D, O'Leary D, Kronmal R, Burke GL, Kuller LH. Relationship between coronary artery calcification and other measures of subclinical cardiovascular disease in older adults. Arterioscler Thromb Vasc Biol. 2002 Oct 1;22(10):1674-9. — View Citation

Newman AB, Naydeck BL, Sutton-Tyrrell K, Feldman A, Edmundowicz D, Kuller LH. Coronary artery calcification in older adults to age 99: prevalence and risk factors. Circulation. 2001 Nov 27;104(22):2679-84. — View Citation

Newman AB, Naydeck BL, Whittle J, Sutton-Tyrrell K, Edmundowicz D, Kuller LH. Racial differences in coronary artery calcification in older adults. Arterioscler Thromb Vasc Biol. 2002 Mar 1;22(3):424-30. — View Citation

Rosano C, Aizenstein H, Cochran J, Saxton J, De Kosky S, Newman AB, Kuller LH, Lopez OL, Carter CS. Functional neuroimaging indicators of successful executive control in the oldest old. Neuroimage. 2005 Dec;28(4):881-9. Epub 2005 Oct 12. — View Citation

Rosano C, Aizenstein HJ, Cochran JL, Saxton JA, De Kosky ST, Newman AB, Kuller LH, Lopez OL, Carter CS. Event-related functional magnetic resonance imaging investigation of executive control in very old individuals with mild cognitive impairment. Biol Psychiatry. 2005 Apr 1;57(7):761-7. — View Citation