Cardiovascular DiseasesNCT00005395
Honolulu Heart Program-Study of Stroke and Dementia
An observational study of Cardiovascular Diseases and Cerebrovascular Accident, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To clarify the relationship of the arterial lesions to aging, define the influence of the arterial changes on the development of stroke, brain infarction, and dementia, and provide a better understanding of vascular dementia. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Cerebrovascular Accident, Cerebrovascular Disorders
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1995to Jul 2000
- 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 clarify the relationship of the arterial lesions to aging, define the influence of the arterial changes on the development of stroke, brain infarction, and dementia, and provide a better understanding of vascular dementia.
Read the detailed description
BACKGROUND:
Morphologic delineation of the arterial lesions will assist the use of experimental models to study molecular mechanisms underlying the lesions and the development of pharmacologic methods for controlling these mechanisms. Further examination of risk factors for the arterial lesions will indicate opportunities for prevention or modifying their evolution.
DESIGN NARRATIVE:
The study was based on data including risk factors and autopsy brain sections from deceased men from the Honolulu Heart Program. In this cohort, medial and intimal lesions of brain parenchymal arteries were significantly associated with brain infarction and three times more common in men dying of stroke than of non-cardiovascular causes. The specific aims of the study were 1) delineation of the morphologic characteristics of the brain parenchymal artery lesions, their regional anatomic distribution, and their relationship to changes in adjacent brain parenchyma and the degree of atherosclerosis in the major intracranial arteries; 2) characterization of the relationship in men between the arterial lesions and advancing age; 3) characterization in men over 60-65 years of age of the relationship of the arterial lesions to stroke, brain infarction or hemorrhage, and dementia; 4) identification of additional risk factors associated with the arterial lesions. The arterial lesions and adjacent brain parenchyma were examined with conventional histologic stains and immunohistochemical markers for specific cellular and extracellular components of the arterial wall. The prevalence and extent of each type of arterial lesion were determined at three anatomic sites. Baseline risk factors thought to be related to stroke and brain infarction were examined for association with the arterial lesions. Statistical tests of association were based on univariate and multivariate linear and logistic regression models controlled, when necessary, for age.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Stroke, Cerebrovascular Disorders, Dementia
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 startSep 1995
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- James Nelson, Louisiana State University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005395
- Sponsor's protocol ID
- 4303
- Other IDs
- R01HL054280
- Status last verified
- Feb 2005
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Nelson JS. Alzheimer pathology in elderly patients with glioblastoma multiforme. Arch Pathol Lab Med. 2002 Dec;126(12):1515-7. doi: 10.5858/2002-126-1515-APIEPW.
PubMed 12456214Kehl F, Pagel PS, Krolikowski JG, Gu W, Toller W, Warltier DC, Kersten JR. Isoflurane does not produce a second window of preconditioning against myocardial infarction in vivo. Anesth Analg. 2002 Nov;95(5):1162-8, table of contents. doi: 10.1097/00000539-200211000-00006.
PubMed 12401584Abbott RD, White LR, Ross GW, Masaki KH, Curb JD, Petrovitch H. Walking and dementia in physically capable elderly men. JAMA. 2004 Sep 22;292(12):1447-53. doi: 10.1001/jama.292.12.1447.
PubMed 15383515
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Honolulu Heart Program-Study of Stroke and Dementia
- ClinicalTrials.gov ID
- NCT00005395
- Acronym / sponsor ID
- 4303
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1995
- Study completion
- Jul 2000 (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 clarify the relationship of the arterial lesions to aging, define the influence of the arterial changes on the development of stroke, brain infarction, and dementia, and provide a better understanding of vascular dementia.
Detailed description
BACKGROUND:
Morphologic delineation of the arterial lesions will assist the use of experimental models to study molecular mechanisms underlying the lesions and the development of pharmacologic methods for controlling these mechanisms. Further examination of risk factors for the arterial lesions will indicate opportunities for prevention or modifying their evolution.
DESIGN NARRATIVE:
The study was based on data including risk factors and autopsy brain sections from deceased men from the Honolulu Heart Program. In this cohort, medial and intimal lesions of brain parenchymal arteries were significantly associated with brain infarction and three times more common in men dying of stroke than of non-cardiovascular causes. The specific aims of the study were 1) delineation of the morphologic characteristics of the brain parenchymal artery lesions, their regional anatomic distribution, and their relationship to changes in adjacent brain parenchyma and the degree of atherosclerosis in the major intracranial arteries; 2) characterization of the relationship in men between the arterial lesions and advancing age; 3) characterization in men over 60-65 years of age of the relationship of the arterial lesions to stroke, brain infarction or hemorrhage, and dementia; 4) identification of additional risk factors associated with the arterial lesions. The arterial lesions and adjacent brain parenchyma were examined with conventional histologic stains and immunohistochemical markers for specific cellular and extracellular components of the arterial wall. The prevalence and extent of each type of arterial lesion were determined at three anatomic sites. Baseline risk factors thought to be related to stroke and brain infarction were examined for association with the arterial lesions. Statistical tests of association were based on univariate and multivariate linear and logistic regression models controlled, when necessary, for age.
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 18 Feb 2016.
- Background: PubMed 12456214Nelson JS. Alzheimer pathology in elderly patients with glioblastoma multiforme. Arch Pathol Lab Med. 2002 Dec;126(12):1515-7. doi: 10.5858/2002-126-1515-APIEPW.
- Background: PubMed 12401584Kehl F, Pagel PS, Krolikowski JG, Gu W, Toller W, Warltier DC, Kersten JR. Isoflurane does not produce a second window of preconditioning against myocardial infarction in vivo. Anesth Analg. 2002 Nov;95(5):1162-8, table of contents. doi: 10.1097/00000539-200211000-00006.
- Background: PubMed 15383515Abbott RD, White LR, Ross GW, Masaki KH, Curb JD, Petrovitch H. Walking and dementia in physically capable elderly men. JAMA. 2004 Sep 22;292(12):1447-53. doi: 10.1001/jama.292.12.1447.
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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.
James Nelson
Louisiana State University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cerebrovascular Accident, 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 18 Feb 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 NCT00005395, which also lists 3 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 18 Feb 2016.