AtherosclerosisNCT00069797
Epidemiology of Coronary Heart Disease in Men Aged 40 and Over
An observational study of Atherosclerosis and Coronary Arteriosclerosis, run by University of Pittsburgh at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 49 years, men only
- Conditions the study is for
- Atherosclerosis, Coronary Arteriosclerosis, Coronary Disease
- How many people
- 1,027 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 49 years
- Men only
- No healthy volunteers
- Adult
Study population: Male community members from geographically defined areas (Pittsburgh, PA, Honolulu, HI, and Japan)
Who may be able to join
- Men aged 40-49 at the time of enrollment
Who cannot join
- -Individuals with clinical cardiovascular disease (coronary heart disease, stroke), and other severe disease
Trial locations and contacts
1 site in 1 country.
United States1 site
130 North Bellefield Avenue, Suite 546
Pittsburgh, Pennsylvania, 15213
About this study
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.
- Conditions
- Atherosclerosis, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases, Cardiovascular Diseases
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Coronary Disease, Heart Diseases, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Intima-media thickness of the carotid artery as well as coronary artery calcification
Measured: first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2003 (estimated)
- Study startSep 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- J. David Curb, MD, MPH, Principal investigator, Pacific Health Research InstituteAkira Sekikawa, MD, PhD, PhD, Principal investigator, University of PittsburghHirotsugu Ueshima, MD, PhD, Principal investigator, Shiga University of Medical Science, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069797
- Sponsor's protocol ID
- 1233
- Other IDs
- R01HL068200-05
- Status last verified
- Jan 2013
- First submitted
- 1 Oct 2003
- Last updated
- 15 Jan 2013
- Results posted
- No
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 12704831Sekikawa 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 12591821Sekikawa 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 15563587Takamiya 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 16325297Kadowaki 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.
PubMed 16446744Kadowaki 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 17142124Okamura 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 16828581Abbott 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 17728270Nakamura 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 17618950Matsunaga-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 17587401El-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 17350026Sekikawa 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 18191046El-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 18094516Choo 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 17983767Choo 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Coronary Heart Disease in Men Aged 40 and Over
- ClinicalTrials.gov ID
- NCT00069797
- Acronym / sponsor ID
- 1233
- Conditions
- Atherosclerosis, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male community members from geographically defined areas (Pittsburgh, PA, Honolulu, HI, and Japan)
Key inclusion criteria (1 listed)
- Men aged 40-49 at the time of enrollment
Key exclusion criteria (1 listed)
- -Individuals with clinical cardiovascular disease (coronary heart disease, stroke), and other severe disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intima-media thickness of the carotid artery as well as coronary artery calcification
Time frame: first visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
- Background: PubMed 12704831Sekikawa 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.
- Background: PubMed 12591821Sekikawa 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.
- Results publication: PubMed 15563587Sekikawa 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.
- Results publication: PubMed 16325297Takamiya 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.
- Results publication: PubMed 16446744Kadowaki 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.
- Results publication: PubMed 17142124Kadowaki 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.
- Results publication: PubMed 16828581Okamura 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.
- Results publication: PubMed 17728270Abbott 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.
- Results publication: PubMed 17618950Nakamura 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.
- Results publication: PubMed 17587401Matsunaga-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.
- Results publication: PubMed 17350026El-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.
- Results publication: PubMed 18191046Sekikawa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Coronary Arteriosclerosis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intima-media thickness of the carotid artery as well as coronary artery calcification (time frame: first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00069797, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2013.