Epidemiology of Coronary Heart Disease in Men Aged 40 and Over
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Purpose
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.
| Condition |
|---|
|
Atherosclerosis Coronary Arteriosclerosis Coronary Disease Heart Diseases Cardiovascular Diseases |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Epidemiology of Coronary Heart Disease in Men Aged 40 and Over |
- Intima-media thickness of the carotid artery as well as coronary artery calcification [ Time Frame: first visit ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood samples (serum and plasma), buffy coat for DNA
| Enrollment: | 1027 |
| Study Start Date: | September 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 49 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Male community members from geographically defined areas (Pittsburgh, PA, Honolulu, HI, and Japan)
Inclusion:
- Men aged 40-49 at the time of enrollment
Exclusion:
-Individuals with clinical cardiovascular disease (coronary heart disease, stroke), and other severe disease
Contacts and Locations| United States, Pennsylvania | |
| 130 North Bellefield Avenue, Suite 546 | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | J. David Curb, MD, MPH | Pacific Health Research Institute |
| Principal Investigator: | Akira Sekikawa, MD, PhD, PhD | University of Pittsburgh |
| Principal Investigator: | Hirotsugu Ueshima, MD, PhD | Shiga University of Medical Science, Japan |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00069797 History of Changes |
| Other Study ID Numbers: | 1233, R01HL068200-05 |
| Study First Received: | October 1, 2003 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia |
Coronary Disease Heart Diseases Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013