CClinicalTrials.gg
CompletedNCT00069797Updated Jan 15, 2013

Epidemiology of Coronary Heart Disease in Men Aged 40 and Over

An observational study in Atherosclerosis, Coronary Arteriosclerosis and Coronary Disease, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to male participants aged 40 Years to 49 Years. Per ClinicalTrials.gov, last updated 2013-01-15.

Sponsored by University of Pittsburgh · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,027
Ages
40 Years to 49 Years
Sex
Male
01

Study 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.

Read the 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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Conditions studied

  • Atherosclerosis
  • Coronary Arteriosclerosis
  • Coronary Disease
  • Heart Diseases
  • Cardiovascular Diseases
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 1,027 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 49 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Male community members from geographically defined areas (Pittsburgh, PA, Honolulu, HI, and Japan)

Inclusion criteria

  • Men aged 40-49 at the time of enrollment

Exclusion criteria

Exclusion:

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

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,027 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Intima-media thickness of the carotid artery as well as coronary artery calcification

    Time frame: first visit

07

Study locations

1 site
  • 130 North Bellefield Avenue, Suite 546
    Pittsburgh, Pennsylvania 15213, United States
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References and documents

Publications

  • Sekikawa A, Okamura T, Kadowaki T, Mitsunami K, Murata K, Kashiwagi A, Nakamura Y, Kanda H, Edmundowicz D, Sutton-Tyrrell K, Curb JD, Kuller LH, Ueshima H. [Electron-beam computed tomography for identification of high-risk persons in primary prevention of coronary heart disease in the United States and its implication for Japan]. Nihon Koshu Eisei Zasshi. 2003 Mar;50(3):183-93. Japanese. PubMed 12704831 ↗
  • Sekikawa A, Horiuchi BY, Edmundowicz D, Ueshima H, Curb JD, Sutton-Tyrrell K, Okamura T, Kadowaki T, Kashiwagi A, Mitsunami K, Murata K, Nakamura Y, Rodriguez BL, Kuller LH. A "natural experiment" in cardiovascular epidemiology in the early 21st century. Heart. 2003 Mar;89(3):255-7. doi: 10.1136/heart.89.3.255. PubMed 12591821 ↗
  • Sekikawa A, Ueshima H, Zaky WR, Kadowaki T, Edmundowicz D, Okamura T, Sutton-Tyrrell K, Nakamura Y, Egawa K, Kanda H, Kashiwagi A, Kita Y, Maegawa H, Mitsunami K, Murata K, Nishio Y, Tamaki S, Ueno Y, Kuller LH. Much lower prevalence of coronary calcium detected by electron-beam computed tomography among men aged 40-49 in Japan than in the US, despite a less favorable profile of major risk factors. Int J Epidemiol. 2005 Feb;34(1):173-9. doi: 10.1093/ije/dyh285. Epub 2004 Nov 24. PubMed 15563587 ↗
  • Takamiya T, Kadowaki T, Zaky WR, Ueshima H, Evans RW, Okamura T, Kashiwagi A, Nakamura Y, Kita Y, Tracy RP, Kuller LH, Sekikawa A. The determinants of plasma plasminogen activator inhibitor-1 levels differ for American and Japanese men aged 40-49. Diabetes Res Clin Pract. 2006 May;72(2):176-82. doi: 10.1016/j.diabres.2005.10.015. Epub 2005 Dec 1. PubMed 16325297 ↗
  • Kadowaki T, Sekikawa A, Murata K, Maegawa H, Takamiya T, Okamura T, El-Saed A, Miyamatsu N, Edmundowicz D, Kita Y, Sutton-Tyrrell K, Kuller LH, Ueshima H. Japanese men have larger areas of visceral adipose tissue than Caucasian men in the same levels of waist circumference in a population-based study. Int J Obes (Lond). 2006 Jul;30(7):1163-5. doi: 10.1038/sj.ijo.0803248. Epub 2006 Jan 31. Erratum In: Int J Obes (Lond). 2012 Oct;36(10):1371. PubMed 16446744 ↗
  • Kadowaki T, Sekikawa A, Okamura T, Takamiya T, Kashiwagi A, Zaky WR, Maegawa H, El-Saed A, Nakamura Y, Evans RW, Edmundowicz D, Kita Y, Kuller LH, Ueshima H. Higher levels of adiponectin in American than in Japanese men despite obesity. Metabolism. 2006 Dec;55(12):1561-3. doi: 10.1016/j.metabol.2006.08.004. PubMed 17142124 ↗
  • Okamura T, Kadowaki T, Sekikawa A, Murata K, Miyamatsu N, Nakamura Y, El-Saed A, Kashiwagi A, Maegawa H, Nishio Y, Takamiya T, Kanda H, Mitsunami K, Kita Y, Edmundowicz D, Tamaki S, Tsujita Y, Kuller LH, Ueshima H. Alcohol consumption and coronary artery calcium in middle-aged Japanese men. Am J Cardiol. 2006 Jul 15;98(2):141-4. doi: 10.1016/j.amjcard.2006.01.095. Epub 2006 May 19. PubMed 16828581 ↗
  • Abbott RD, Ueshima H, Rodriguez BL, Kadowaki T, Masaki KH, Willcox BJ, Sekikawa A, Kuller LH, Edmundowicz D, Shin C, Kashiwagi A, Nakamura Y, El-Saed A, Okamura T, White R, Curb JD. Coronary artery calcification in Japanese men in Japan and Hawaii. Am J Epidemiol. 2007 Dec 1;166(11):1280-7. doi: 10.1093/aje/kwm201. Epub 2007 Aug 28. PubMed 17728270 ↗
  • Nakamura Y, Ueno Y, Tamaki S, Kadowaki T, Okamura T, Kita Y, Miyamatsu N, Sekikawa A, Takamiya T, El-Saed A, Sutton-Tyrrell K, Ueshima H. Fish consumption and early atherosclerosis in middle-aged men. Metabolism. 2007 Aug;56(8):1060-4. doi: 10.1016/j.metabol.2007.03.014. PubMed 17618950 ↗
  • Matsunaga-Irie S, Ueshima H, Zaky WR, Kadowaki T, Evans RW, Okamura T, Takamiya T, Kita Y, Kuller LH, Sekikawa A. Serum ghrelin levels are higher in Caucasian men than Japanese men aged 40-49 years. Diabetes Obes Metab. 2007 Jul;9(4):591-3. doi: 10.1111/j.1463-1326.2006.00627.x. PubMed 17587401 ↗
  • El-Saed A, Sekikawa A, Edmundowicz D, Evans RW, Sutton-Tyrrell K, Kadowaki T, Choo J, Takamiya T, Kuller LH. Coronary calcification is more predictive of carotid intimal medial thickness in black compared to white middle aged men. Atherosclerosis. 2008 Feb;196(2):913-8. doi: 10.1016/j.atherosclerosis.2007.02.009. Epub 2007 Mar 9. PubMed 17350026 ↗
  • Sekikawa A, Ueshima H, Sutton-Tyrrell K, Kadowaki T, El-Saed A, Okamura T, Takamiya T, Ueno Y, Evans RW, Nakamura Y, Edmundowicz D, Kashiwagi A, Maegawa H, Kuller LH. Intima-media thickness of the carotid artery and the distribution of lipoprotein subclasses in men aged 40 to 49 years between whites in the United States and the Japanese in Japan for the ERA JUMP study. Metabolism. 2008 Feb;57(2):177-82. doi: 10.1016/j.metabol.2007.08.022. PubMed 18191046 ↗
  • El-Saed A, Sekikawa A, Zaky RW, Kadowaki T, Takamiya T, Okamura T, Edmundowicz D, Kita Y, Kuller LH, Ueshima H. Association of lipoprotein-associated phospholipase A2 with coronary calcification among American and Japanese men. J Epidemiol. 2007 Nov;17(6):179-85. doi: 10.2188/jea.17.179. PubMed 18094516 ↗
  • Choo J, Ueshima H, Jang Y, Sutton-Tyrrell K, El-Saed A, Kadowaki T, Takamiya T, Okamura T, Ueno Y, Nakamura Y, Sekikawa A, Curb JD, Kuller LH, Shin C. Difference in carotid intima-media thickness between Korean and Japanese men. Ann Epidemiol. 2008 Apr;18(4):310-5. doi: 10.1016/j.annepidem.2007.08.002. Epub 2007 Nov 5. PubMed 17983767 ↗
  • Choo J, Ueshima H, Curb JD, Shin C, Evans RW, El-Saed A, Kadowaki T, Okamura T, Nakata K, Otake T, Miura K, Abbott RD, Sutton-Tyrrell K, Edmundowicz D, Kuller LH, Sekikawa A; ERA-JUMP Study Group. Serum n-6 fatty acids and lipoprotein subclasses in middle-aged men: the population-based cross-sectional ERA-JUMP study. Am J Clin Nutr. 2010 May;91(5):1195-203. doi: 10.3945/ajcn.2009.28500. Epub 2010 Mar 31. PubMed 20357040 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00069797
Lead sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Oct 6, 2003
Start date
Sep 2003
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Jan 15, 2013

Study contacts

J. David Curb, MD, MPH
principal investigator · Pacific Health Research Institute
Akira Sekikawa, MD, PhD, PhD
principal investigator · University of Pittsburgh
Hirotsugu Ueshima, MD, PhD
principal investigator · Shiga University of Medical Science, Japan
View the source record on ClinicalTrials.gov ↗

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