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| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | September 1995 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005395 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Honolulu Heart Program-Study of Stroke and Dementia | ||||
| Official Title ICMJE | |||||
| Brief 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | July 2000 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Male | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005395 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 4303 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | February 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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