Epidemiology of Coronary Heart Disease in Men Aged 40 and Over
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| First Received Date ICMJE | October 1, 2003 | ||||||||||||
| Last Updated Date | January 14, 2013 | ||||||||||||
| Start Date ICMJE | September 2003 | ||||||||||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Intima-media thickness of the carotid artery as well as coronary artery calcification [ Time Frame: first visit ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT00069797 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Epidemiology of Coronary Heart Disease in Men Aged 40 and Over | ||||||||||||
| Official Title ICMJE | Epidemiology of Coronary Heart Disease in Men Aged 40 and Over | ||||||||||||
| Brief Summary | To examine whether the prevalence of subclinical coronary and aortic atherosclerotic disease is different among Japanese in Japan, Japanese in Hawaii, and black and white Americans. |
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| Detailed Description | BACKGROUND: Substantial change toward a more Westernized lifestyle has taken place among younger individuals who were born after World War II (WWII) in non-Western countries including Japan. Data from national sample surveys in Japan clearly demonstrate that risk factor profiles for coronary heart disease (CHD) are very similar to those in the United States (US) in this post WWII cohort. Men in Japan do have a considerably higher prevalence of cigarette smoking and men in the US have a higher prevalence of obesity. CHD mortality among men in Japan is, however, still less than a half of that in the US. Careful review of mortality statistics confirms this. This difference remains unique among industrialized countries. DESIGN NARRATIVE: The study is a collaboration between Dr. Akira Sekikawa at the University of Pittsburgh and Dr. J. David Curb of the Pacific Health Research Institute in Honolulu, Hawaii. The study tests the null hypothesis that there are no differences in the extent of atherosclerosis among Japanese men in Japan, Japanese American men in Hawaii, and US white and black men in this post WWII birth cohort. The project is based on recent and ongoing successful Japan/US collaborations in the INTERMAP, INTERLIPID and Honolulu Heart Program studies including development of the first standardized US/Japan diet tables. The investigators will examine 300 white men and 100 black men aged 40-49, randomly selected from Allegheny County, PA, 300 Japanese American men aged 40-49 from the population-based sample recruited from the offspring of the members of the Honolulu Heart Program cohort, and 300 Japanese men aged 40-49, randomly selected from Kusatsu City, Japan. The Japanese recruitment and examination has already been supported in Japan. The extent of atherosclerosis and risk factor profiles for CHD will be evaluated and compared, as well as the relationship of specific risk factors to the measures of atherosclerosis. The measures of subclinical disease proposed include calcium scores of coronary artery and aorta measured by electron beam computed tomography (EBCT) and carotid intima thickness measured by ultrasound. Other proposed measures include dietary intake by food frequency questionnaire, total cholesterol, LDLc, HDLc, lipids by NMR spectroscopy, blood pressure, cigarette smoking, thiocyanate, omega-3 fatty acid, alcohol consumption, body mass index (BMI), intra-abdominal fat, and others. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Retention: Samples With DNA Description: Blood samples (serum and plasma), buffy coat for DNA |
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| Sampling Method | Probability Sample | ||||||||||||
| Study Population | Male community members from geographically defined areas (Pittsburgh, PA, Honolulu, HI, and Japan) |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 1027 | ||||||||||||
| Completion Date | July 2008 | ||||||||||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion: - Men aged 40-49 at the time of enrollment Exclusion: -Individuals with clinical cardiovascular disease (coronary heart disease, stroke), and other severe disease |
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| Gender | Male | ||||||||||||
| Ages | 40 Years to 49 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00069797 | ||||||||||||
| Other Study ID Numbers ICMJE | 1233, R01HL068200-05 | ||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||
| Responsible Party | University of Pittsburgh | ||||||||||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||||||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||||||||||
| Verification Date | January 2013 | ||||||||||||
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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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