Cardiovascular DiseasesNCT00005230
Epidemiology of Carotid Disease in Elderly Adults
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine whether a population with isolated systolic hypertension (ISH) had a higher prevalence of carotid disease than a normotensive population matched for age and sex, and to determine specific risk factors for carotid disease. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1988to Jun 2003
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine whether a population with isolated systolic hypertension (ISH) had a higher prevalence of carotid disease than a normotensive population matched for age and sex, and to determine specific risk factors for carotid disease.
Read the detailed description
BACKGROUND:
The Systolic Hypertension in the Elderly Program was a multicenter controlled clinical trial supported by the NHLBI to study the cardiovascular and psychological effects of isolated systolic hypertension in the elderly and to determine the efficacy and evaluate possible adverse effects of drug treatment for this condition. A total of 4,736 patients were followed until 1991. Elderly individuals with isolated systolic hypertension are clearly at increased risk of both heart attack and stroke. This group has been shown in pilot studies to also have high prevalence of carotid disease and lower extremity arterial disease. Selected risk factors such as older age, male sex, and smoking were found to be related to an increased prevalence of disease. This study allowed validation of these initial observations.
DESIGN NARRATIVE:
This study was ancillary to the Systolic Hypertension in the Elderly Program (SHEP) clinical trial. Participants of the SHEP at the University of Pittsburgh were used for the hypertensive population. Patients screened for SHEP but rejected because of normal blood pressure were used for the controls. Carotid disease was assessed by duplex scanning, a noninvasive technique that combined real time B-mode ultrasound with Doppler ultrasound, producing a system capable of both vessel imaging and analysis of blood flow characteristics. Other evaluations included ankle systolic blood pressure measurements to detect lower extremity arterial disease, complete history and physical examination, electrocardiogram, blood lipoprotein levels, fasting insulin and glucose levels, hemoglobin, and hematocrit. Thus, the effects of various risk factors on the development of carotid atherosclerosis were evaluated as well as the relationship between carotid atherosclerosis and peripheral arterial disease of the lower extremities. The first six months of the study consisted of preparation and reproducibility testing of duplex scan measurements. During the following three years, duplex scans and other evaluations were completed on all 400 participants. During the final half of the fourth year, the first 100 duplex scans of hypertensive participants were repeated to determine whether it was possible to measure disease progression using this methodology. The study began in FY 1988 under R29HL39871 and continued in FY 1993 under R01HL50439.
The study was renewed in 1998 for an additional three years through June, 2003. The study continued to investigate the prevalence and prognostic value of subclinical atherosclerosis in the Pittsburgh SHEP cohort and a cohort of normotensive controls. Annual telephone follow-up of the remaining 178 SHEP participants and 168 controls continued. A final clinic visit included 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 was striking with event rates for the active and placebo groups continuing to diverge beyond 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 were 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 supplemented the extensive data on subclinical atherosclerosis already available for this cohort. The extent to which these measures predicted cardiovascular events was evaluated.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Carotid Artery Diseases, Atherosclerosis
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Carotid Artery Diseases, Atherosclerosis
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 startJul 1988
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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 National Heart, Lung, and Blood Institute (NHLBI)The 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
- Sponsor type
- US National Institutes of Health
- Investigators
- Kim Tyrrell, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005230
- Sponsor's protocol ID
- 1110
- Other IDs
- R29HL039871
- Status last verified
- Dec 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Sutton-Tyrrell K, Wolfson SK Jr, Thompson T, Kelsey SF. Measurement variability in duplex scan assessment of carotid atherosclerosis. Stroke. 1992 Feb;23(2):215-20. doi: 10.1161/01.str.23.2.215.
PubMed 1561650Sparrow D, O'Connor GT, Rosner B, Weiss ST. Methacholine airway responsiveness and 24-hour urine excretion of sodium and potassium. The Normative Aging Study. Am Rev Respir Dis. 1991 Sep;144(3 Pt 1):722-5. doi: 10.1164/ajrccm/144.3_Pt_1.722.
PubMed 1892316Sutton-Tyrrell K, Alcorn HG, Herzog H, Kelsey SF, Kuller LH. Morbidity, mortality, and antihypertensive treatment effects by extent of atherosclerosis in older adults with isolated systolic hypertension. Stroke. 1995 Aug;26(8):1319-24. doi: 10.1161/01.str.26.8.1319.
PubMed 7631329Sutton-Tyrrell K, Wolfson SK Jr, Kuller LH. Blood pressure treatment slows the progression of carotid stenosis in patients with isolated systolic hypertension. Stroke. 1994 Jan;25(1):44-50. doi: 10.1161/01.str.25.1.44.
PubMed 8266382Sutton-Tyrrell K, Alcorn HG, Wolfson SK Jr, Kelsey SF, Kuller LH. Predictors of carotid stenosis in older adults with and without isolated systolic hypertension. Stroke. 1993 Mar;24(3):355-61. doi: 10.1161/01.str.24.3.355.
PubMed 8446969Zeigler-Johnson CM, Holmes JL, Lassila HC, Sutton-Tyrrell K, Kuller LH. Subclinical atherosclerosis in relation to hysterectomy status in black women. Stroke. 1998 Apr;29(4):759-64. doi: 10.1161/01.str.29.4.759.
PubMed 9550508Franklin SS, Sutton-Tyrrell K, Belle SH, Weber MA, Kuller LH. The importance of pulsatile components of hypertension in predicting carotid stenosis in older adults. J Hypertens. 1997 Oct;15(10):1143-50. doi: 10.1097/00004872-199715100-00012.
PubMed 9350588Sutton-Tyrrell K, Bostom A, Selhub J, Zeigler-Johnson C. High homocysteine levels are independently related to isolated systolic hypertension in older adults. Circulation. 1997 Sep 16;96(6):1745-9. doi: 10.1161/01.cir.96.6.1745.
PubMed 9323056Lassila HC, Sutton-Tyrrell K, Schwartz F, et al: Antihypertensive Medication Use 5 Years Following the Systolic Hypertension in the Elderly Program. CVD Prevention, 3:229-234, 2000.
Evans RW, Sankey SS, Hauth BA, Sutton-Tyrrell K, Kamboh MI, Kuller LH. Effect of sample storage on quantitation of lipoprotein(a) by an enzyme-linked immunosorbent assay. Lipids. 1996 Nov;31(11):1197-203. doi: 10.1007/BF02524295.
PubMed 8934453Sutton-Tyrrell K, Wildman R, Newman A, Kuller LH. Extent of cardiovascular risk reduction associated with treatment of isolated systolic hypertension. Arch Intern Med. 2003 Dec 8-22;163(22):2728-31. doi: 10.1001/archinte.163.22.2728.
PubMed 14662626
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Carotid Disease in Elderly Adults
- ClinicalTrials.gov ID
- NCT00005230
- Acronym / sponsor ID
- 1110
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Carotid Artery Diseases, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1988
- Study completion
- Jun 2003 (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 determine whether a population with isolated systolic hypertension (ISH) had a higher prevalence of carotid disease than a normotensive population matched for age and sex, and to determine specific risk factors for carotid disease.
Detailed description
BACKGROUND:
The Systolic Hypertension in the Elderly Program was a multicenter controlled clinical trial supported by the NHLBI to study the cardiovascular and psychological effects of isolated systolic hypertension in the elderly and to determine the efficacy and evaluate possible adverse effects of drug treatment for this condition. A total of 4,736 patients were followed until 1991. Elderly individuals with isolated systolic hypertension are clearly at increased risk of both heart attack and stroke. This group has been shown in pilot studies to also have high prevalence of carotid disease and lower extremity arterial disease. Selected risk factors such as older age, male sex, and smoking were found to be related to an increased prevalence of disease. This study allowed validation of these initial observations.
DESIGN NARRATIVE:
This study was ancillary to the Systolic Hypertension in the Elderly Program (SHEP) clinical trial. Participants of the SHEP at the University of Pittsburgh were used for the hypertensive population. Patients screened for SHEP but rejected because of normal blood pressure were used for the controls. Carotid disease was assessed by duplex scanning, a noninvasive technique that combined real time B-mode ultrasound with Doppler ultrasound, producing a system capable of both vessel imaging and analysis of blood flow characteristics. Other evaluations included ankle systolic blood pressure measurements to detect lower extremity arterial disease, complete history and physical examination, electrocardiogram, blood lipoprotein levels, fasting insulin and glucose levels, hemoglobin, and hematocrit. Thus, the effects of various risk factors on the development of carotid atherosclerosis were evaluated as well as the relationship between carotid atherosclerosis and peripheral arterial disease of the lower extremities. The first six months of the study consisted of preparation and reproducibility testing of duplex scan measurements. During the following three years, duplex scans and other evaluations were completed on all 400 participants. During the final half of the fourth year, the first 100 duplex scans of hypertensive participants were repeated to determine whether it was possible to measure disease progression using this methodology. The study began in FY 1988 under R29HL39871 and continued in FY 1993 under R01HL50439.
The study was renewed in 1998 for an additional three years through June, 2003. The study continued to investigate the prevalence and prognostic value of subclinical atherosclerosis in the Pittsburgh SHEP cohort and a cohort of normotensive controls. Annual telephone follow-up of the remaining 178 SHEP participants and 168 controls continued. A final clinic visit included 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 was striking with event rates for the active and placebo groups continuing to diverge beyond 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 were 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 supplemented the extensive data on subclinical atherosclerosis already available for this cohort. The extent to which these measures predicted cardiovascular events was evaluated.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 May 2016.
- Background: PubMed 1561650Sutton-Tyrrell K, Wolfson SK Jr, Thompson T, Kelsey SF. Measurement variability in duplex scan assessment of carotid atherosclerosis. Stroke. 1992 Feb;23(2):215-20. doi: 10.1161/01.str.23.2.215.
- Background: PubMed 1892316Sparrow D, O'Connor GT, Rosner B, Weiss ST. Methacholine airway responsiveness and 24-hour urine excretion of sodium and potassium. The Normative Aging Study. Am Rev Respir Dis. 1991 Sep;144(3 Pt 1):722-5. doi: 10.1164/ajrccm/144.3_Pt_1.722.
- Background: PubMed 7631329Sutton-Tyrrell K, Alcorn HG, Herzog H, Kelsey SF, Kuller LH. Morbidity, mortality, and antihypertensive treatment effects by extent of atherosclerosis in older adults with isolated systolic hypertension. Stroke. 1995 Aug;26(8):1319-24. doi: 10.1161/01.str.26.8.1319.
- Background: PubMed 8266382Sutton-Tyrrell K, Wolfson SK Jr, Kuller LH. Blood pressure treatment slows the progression of carotid stenosis in patients with isolated systolic hypertension. Stroke. 1994 Jan;25(1):44-50. doi: 10.1161/01.str.25.1.44.
- Background: PubMed 8446969Sutton-Tyrrell K, Alcorn HG, Wolfson SK Jr, Kelsey SF, Kuller LH. Predictors of carotid stenosis in older adults with and without isolated systolic hypertension. Stroke. 1993 Mar;24(3):355-61. doi: 10.1161/01.str.24.3.355.
- Background: PubMed 9550508Zeigler-Johnson CM, Holmes JL, Lassila HC, Sutton-Tyrrell K, Kuller LH. Subclinical atherosclerosis in relation to hysterectomy status in black women. Stroke. 1998 Apr;29(4):759-64. doi: 10.1161/01.str.29.4.759.
- Background: PubMed 9350588Franklin SS, Sutton-Tyrrell K, Belle SH, Weber MA, Kuller LH. The importance of pulsatile components of hypertension in predicting carotid stenosis in older adults. J Hypertens. 1997 Oct;15(10):1143-50. doi: 10.1097/00004872-199715100-00012.
- Background: PubMed 9323056Sutton-Tyrrell K, Bostom A, Selhub J, Zeigler-Johnson C. High homocysteine levels are independently related to isolated systolic hypertension in older adults. Circulation. 1997 Sep 16;96(6):1745-9. doi: 10.1161/01.cir.96.6.1745.
- BackgroundLassila HC, Sutton-Tyrrell K, Schwartz F, et al: Antihypertensive Medication Use 5 Years Following the Systolic Hypertension in the Elderly Program. CVD Prevention, 3:229-234, 2000.
- Background: PubMed 8934453Evans RW, Sankey SS, Hauth BA, Sutton-Tyrrell K, Kamboh MI, Kuller LH. Effect of sample storage on quantitation of lipoprotein(a) by an enzyme-linked immunosorbent assay. Lipids. 1996 Nov;31(11):1197-203. doi: 10.1007/BF02524295.
- Background: PubMed 14662626Sutton-Tyrrell K, Wildman R, Newman A, Kuller LH. Extent of cardiovascular risk reduction associated with treatment of isolated systolic hypertension. Arch Intern Med. 2003 Dec 8-22;163(22):2728-31. doi: 10.1001/archinte.163.22.2728.
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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.
Kim Tyrrell
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 May 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 NCT00005230, which also lists 11 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 May 2016.