Viewing Study NCT00069797



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Study NCT ID: NCT00069797
Status: COMPLETED
Last Update Posted: 2013-01-15
First Post: 2003-10-01

Brief Title: Epidemiology of Coronary Heart Disease in Men Aged 40 and Over
Sponsor: University of Pittsburgh
Organization: University of Pittsburgh

Study Overview

Official Title: Epidemiology of Coronary Heart Disease in Men Aged 40 and Over
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 JapanUS collaborations in the INTERMAP INTERLIPID and Honolulu Heart Program studies including development of the first standardized USJapan 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL068200-05 NIH None httpsreporternihgovquickSearchR01HL068200-05