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Epidemiology of Coronary Heart Disease in Men Aged 40 and Over

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ClinicalTrials.gov Identifier: NCT00069797
Recruitment Status : Completed
First Posted : October 6, 2003
Last Update Posted : January 15, 2013
Information provided by (Responsible Party):

October 1, 2003
October 6, 2003
January 15, 2013
September 2003
July 2008   (Final data collection date for primary outcome measure)
Intima-media thickness of the carotid artery as well as coronary artery calcification [ Time Frame: first visit ]
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Complete list of historical versions of study NCT00069797 on ClinicalTrials.gov Archive Site
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Epidemiology of Coronary Heart Disease in Men Aged 40 and Over
Epidemiology of Coronary Heart Disease in Men Aged 40 and Over
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.


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.


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.

Observational Model: Cohort
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Blood samples (serum and plasma), buffy coat for DNA
Probability Sample
Male community members from geographically defined areas (Pittsburgh, PA, Honolulu, HI, and Japan)
  • Atherosclerosis
  • Coronary Arteriosclerosis
  • Coronary Disease
  • Heart Diseases
  • Cardiovascular Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2008
July 2008   (Final data collection date for primary outcome measure)


- Men aged 40-49 at the time of enrollment


-Individuals with clinical cardiovascular disease (coronary heart disease, stroke), and other severe disease

Sexes Eligible for Study: Male
40 Years to 49 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01HL068200-05 ( U.S. NIH Grant/Contract )
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University of Pittsburgh
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
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
University of Pittsburgh
January 2013