Cardiovascular DiseasesNCT00005756
Epidemiology of Coronary Calcification in the Elderly
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Pittsburgh.
Trial summary
To investigate the prevalence and prognostic value of subclinical atherosclerosis in the Pittsburgh SHEP cohort and a cohort of normal controls. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Arteriosclerosis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1999to Jul 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: 614 older adults aged, on average, 80 years (range, 67 to 99 years); 367 (60%) were women, and 143 (23%) were black.
Who may be able to join
- 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
Who cannot join
- Inability to give informed consent at time of EBCT scan Unable to travel to study center Lives in nursing home.
About this study
To investigate the prevalence and prognostic value of subclinical atherosclerosis in the Pittsburgh SHEP cohort and a cohort of normal controls.
Read the 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 U.S. population.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Arteriosclerosis, Coronary Disease, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Artery Disease, Coronary Disease, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startAug 1999
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Anne B. Newman, University of Pittsburgh
- Investigators
- Anne B. Newman, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005756
- Sponsor's protocol ID
- 5111
- Other IDs
- R01HL064587
- Status last verified
- Jan 2016
- First submitted
- 25 May 2000
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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. doi: 10.1161/hc4601.099464.
PubMed 11723018Newman 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. doi: 10.1161/01.atv.0000033540.89672.24.
PubMed 12377748Newman 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. doi: 10.1161/hq0302.105357.
PubMed 11884285Rosano 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. doi: 10.1016/j.biopsych.2004.12.031.
PubMed 15820233Rosano 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. doi: 10.1016/j.neuroimage.2005.05.059. Epub 2005 Oct 12.
PubMed 16226041
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Coronary Calcification in the Elderly
- ClinicalTrials.gov ID
- NCT00005756
- Acronym / sponsor ID
- 5111
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Arteriosclerosis, Coronary Disease, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 1999
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 U.S. population.
Study design
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 614 older adults aged, on average, 80 years (range, 67 to 99 years); 367 (60%) were women, and 143 (23%) were black.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to give informed consent at time of EBCT scan Unable to travel to study center Lives in nursing home.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Background: PubMed 11723018Newman 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. doi: 10.1161/hc4601.099464.
- Background: PubMed 12377748Newman 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. doi: 10.1161/01.atv.0000033540.89672.24.
- Background: PubMed 11884285Newman 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. doi: 10.1161/hq0302.105357.
- Background: PubMed 15820233Rosano 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. doi: 10.1016/j.biopsych.2004.12.031.
- Background: PubMed 16226041Rosano 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. doi: 10.1016/j.neuroimage.2005.05.059. Epub 2005 Oct 12.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne B. Newman, MD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005756, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.