Cardiovascular DiseasesNCT00005123
Honolulu Heart Program
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate coronary heart disease and stroke among American men of Japanese ancestry who were living on the island of Oahu in 1965. Morbidity and mortality surveillance of the original cohort is continuing. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Cerebrovascular Accident
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1965to Sep 2002
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate coronary heart disease and stroke among American men of Japanese ancestry who were living on the island of Oahu in 1965. Morbidity and mortality surveillance of the original cohort is continuing.
Read the detailed description
BACKGROUND:
The Honolulu Heart Program was initiated to verify reports that men of Japanese ancestry living in the United States had a much higher risk of coronary heart disease and a lower risk of stroke than Japanese men in Japan. The Honolulu Heart Program was actually a component of the larger NI-HON-SAN Study. The NI-HON-SAN Study (from the acronyms Nippon, Honolulu, and San Francisco) was initiated in 1965. The populations under investigation included members of the Honolulu Heart Program as well as men of Japanese ancestry born between 1900 and 1919 and residing in Japan and San Francisco.
In the Honolulu Heart Program, 11,148 men were identified of whom 8,006 participated in baseline examinations between 1965 and 1968. The 1965 - 1968 examination included a detailed medical and social history with specific inquiries about smoking, alcohol consumption, diet, and physical activity. A physical examination focussed on the cardiovascular system; laboratory tests included hematocrit, serum cholesterol, triglyceride, uric acid, glucose determination, and urinalysis. A twelve lead electrocardiogram and lung function testing revealed that 301 men had evidence of coronary heart disease and 111 had a stroke. The prevalence of coronary heart disease was slightly higher than in the comparable population in Japan, but the incidence rate during the first two-year period of follow-up was twice as high in Honolulu as in Japan. Stroke prevalence was much higher in Japan than in the Honolulu cohort, with a threefold difference. The Honolulu Japanese men were more obese, ate a more Westernized diet with a higher amount of animal protein, saturated fat, and sucrose and a smaller amount of complex carbohydrates. They had higher levels of serum cholesterol, triglyceride, uric acid, and glucose than Japanese men in Japan. Cigarette smoking was more common in the Japanese cohort, while the proportion of heavy smokers was greater in the Honolulu cohort. Alcohol consumption in the Japanese cohort was twice that of the Honolulu cohort. There were no differences in mean blood pressure or prevalence of hypertension. Repeat examinations were performed near the second and sixth anniversaries of the initial examinations. The six year follow-up data identified 294 new cases of coronary heart disease and 133 new cases of stroke. Between 1970 and 1972 some 2,800 of the cohort were examined and had lipoprotein determinations performed as part of the NHLBI Lipoprotein Phenotyping Project. Survivors of the lipoprotein cohort were reexamined between 1975 and 1978 near the tenth anniversary of their initial examination and again between 1980 and 1982.
In 1985, the program was enlarged to make a comparative analysis of the 12-year incidence of coronary heart disease in the Japanese and Hawaii study cohort of the original NI-HON-SAN Study, to sample 400 offspring of the study cohort ages 45 to 60 years and to complete nutrient indicators for association with blood pressure in a manner consistent with the United States-Japan study of nutrition and blood pressure. Resulting data were compared with a comparable selected group of Japanese men and with the parents of the offspring to examine familial associations. Pulmonary function data were recorded and analyzed for association with other risk factors, respiratory disease, and other major chronic diseases.
Beginning in March 1993 and continuing through December 1994, the National Institute on Aging, with its own funds, investigated aging and dementia among Honolulu Heart Program participants.
Beginning in March 1997, the study was supported by U01HL56274.
DESIGN NARRATIVE:
In this prospective cohort study, the hospital discharge rosters of all general hospitals on the Island of Oahu were reviewed twice yearly as part of the morbidity and mortality surveillance. The appropriate chart materials were abstracted for review by study physicians for evidence of myocardial infarction and stroke. Beginning in 1986, both old and new hospital discharge records were reviewed for the additional endpoints of congestive heart failure, aortic aneurysm, bronchitis, emphysema, asthma, chronic obstructive lung disease, dementia, organic brain syndrome, and Parkinson's disease. Deaths were monitored by following obituary columns as well as reviewing death certificates from the State Health Department. There was daily contact with hospitals to find out about impending autopsies in which study personnel could participate. However, only 20-25 percent of the deaths had protocol autopsies.
The fifth and final complete examination of the surviving cohort concluded in Spring, 1996 under a contract with the National Institute on Aging. While the emphasis of this exam was the investigation of dementia, NHLBI funded the recording of blood pressures and ECGs as well as the continued surveillance for morbidity and mortality. A cooperative agreement extends the surveillance for an additional five years. As part of the close-out phase of the study, frozen blood samples collected since the study's inception have been sent to a repository in Rockville, MD. A review board for screening prospective users of this resource holds quarterly meetings.
As the study group includes both migrants from Japan and Hawaii-born men, there is a spectrum of cultural lifestyles and varying grades of acculturation which are being examined as risk factors for cardiovascular and other chronic diseases. The existing baseline and follow-up examination data and the surveillance information on the incidence of most major diseases provide opportunities for a great variety of research projects concerning the predictors of cardiovascular disease, as well as studies of the broader concepts of health and disease in the aging population. The low out-migration rate and the well-defined sources of medical care have provided an ideal setting for maintaining disease morbidity and mortality surveillance; nearly 100 per cent of hospital discharge episodes have been recorded. As the study participants range in age from 75-95 in 1996, the rates of coronary heart disease, stroke, and other chronic diseases are increasing rapidly and thus are providing a large number of disease endpoints for study. Other Institutes are also currently supporting activities which utilize the original cohort.
Stored sera provide an opportunity to test new ideas and etiologic hypotheses using both prospective and case-control study designs. Protocol autopsy information can now be utilized to examine relationships among risk factors, clinical manifestations of CHD, and stroke and pathological evidence of atherosclerosis.
Beginning in 1997, a cooperative agreement extends the surveillance for an additional five years through February, 2002. As part of the close-out of the study, frozen blood samples collected since the study's inception have been sent to a repository in Rockville, Maryland.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Cerebrovascular Accident, Heart Diseases, Heart Failure, Congestive, Myocardial Infarction
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Stroke, Heart Diseases, Heart Failure, Myocardial Infarction, Asthma, Emphysema
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1965
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (245)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- J. Curb, Kuakini Medical CenterJess Curb, Kuakini Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005123
- Sponsor's protocol ID
- 902
- Status last verified
- Sep 2004
- First submitted
- 25 May 2000
- Last updated
- 14 Apr 2016
- Results posted
- No
Publications
Rhoads GG. Hemoglobin A1c reproducibility. Ann Intern Med. 1980 Apr;92(4):574. doi: 10.7326/0003-4819-92-4-574. No abstract available.
PubMed 7362177McGee D, Rhoads G, Feinleib M: The Logistic Function. A Model for Assessing Risk of Heart Disease. In Proceedings of the Fourteenth Hawaii International Conference on System Sciences. Edited by B. Shriver et al. Honolulu, Hawaii, University of Hawaii Press pp 722-740, 1981
Blackwelder WC, Kagan A, Gordon T, Rhoads GG. Comparison of methods for diagnosing angina pectoris: the Honolulu heart study. Int J Epidemiol. 1981 Sep;10(3):211-5. doi: 10.1093/ije/10.3.211.
PubMed 7287281Gordon T, Kagan A, Garcia-Palmieri M, Kannel WB, Zukel WJ, Tillotson J, Sorlie P, Hjortland M. Diet and its relation to coronary heart disease and death in three populations. Circulation. 1981 Mar;63(3):500-15. doi: 10.1161/01.cir.63.3.500.
PubMed 7460234Kagan A, McGee DL, Yano K, Rhoads GG, Nomura A. Serum cholesterol and mortality in a Japanese-American population: the Honolulu Heart program. Am J Epidemiol. 1981 Jul;114(1):11-20. doi: 10.1093/oxfordjournals.aje.a113157.
PubMed 7246518Kagan A, Yano K, Rhoads GG, McGee DL. Alcohol and cardiovascular disease: the Hawaiian experience. Circulation. 1981 Sep;64(3 Pt 2):III 27-31.
PubMed 7261298Reed D, McGee D, Yano K. Biological and social correlates of blood pressure among Japanese men in Hawaii. Hypertension. 1982 May-Jun;4(3):406-14. doi: 10.1161/01.hyp.4.3.406.
PubMed 7068196Yano K, Kagan A, McGee D, Rhoads GG. Glucose intolerance and nine-year mortality in Japanese men in Hawaii. Am J Med. 1982 Jan;72(1):71-80. doi: 10.1016/0002-9343(82)90580-0.
PubMed 7058826McGee D, Rhoads G, Hankin J, Yano K, Tillotson J. Within-person variability of nutrient intake in a group of Hawaiian men of Japanese ancestry. Am J Clin Nutr. 1982 Oct;36(4):657-63. doi: 10.1093/ajcn/36.4.657.
PubMed 7124667Reed D, McGee D, Cohen J, Yano K, Syme SL, Feinleib M. Acculturation and coronary heart disease among Japanese men in Hawaii. Am J Epidemiol. 1982 Jun;115(6):894-905. doi: 10.1093/oxfordjournals.aje.a113377.
PubMed 7091147Kagan A, Yano K, McGee D, Rhoads GG: Epidemiology of Glucose Intolerance in Hawaii Japanese Men. Excerpta Medica. In: Genetic-Enviornmental Interaction in Diabetes Mellitus, Proceedings of the Third Symposium on Diabetes Mellitus in Asia and Oceania; Honolulu Feb 6-7, 1981; ISBN Elsevier North Holland, (International Congress Series No. 549, pp 51-56, 1982
Hulley SB, Rhoads GG. The plasma lipoproteins as risk factors: comparison of electrophoretic and ultracentrifugation results. Metabolism. 1982 Aug;31(8):773-7. doi: 10.1016/0026-0495(82)90074-9.
PubMed 6954343Yamamoto L, Yano K, Rhoads GG. Characteristics of joggers among Japanese men in Hawaii. Am J Public Health. 1983 Feb;73(2):147-52. doi: 10.2105/ajph.73.2.147.
PubMed 6849472Yano K, McGee D, Reed DM. The impact of elevated blood pressure upon 10-year mortality among Japanese men in Hawaii: the Honolulu Heart Program. J Chronic Dis. 1983;36(8):569-79. doi: 10.1016/0021-9681(83)90145-5.
PubMed 6885958Reed D, McGee D, Yano K. Trends of coronary heart disease among men of Japanese ancestry in Hawaii. J Community Health. 1983 Spring;8(3):149-59. doi: 10.1007/BF01666450.
PubMed 6875040
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Honolulu Heart Program
- ClinicalTrials.gov ID
- NCT00005123
- Acronym / sponsor ID
- 902
- Conditions
- Cardiovascular Diseases, Coronary Disease, Cerebrovascular Accident, Heart Diseases, Heart Failure, Congestive, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1965
- Study completion
- Sep 2002
- First posted
- 26 May 2000 (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 investigate coronary heart disease and stroke among American men of Japanese ancestry who were living on the island of Oahu in 1965. Morbidity and mortality surveillance of the original cohort is continuing.
Detailed description
BACKGROUND:
The Honolulu Heart Program was initiated to verify reports that men of Japanese ancestry living in the United States had a much higher risk of coronary heart disease and a lower risk of stroke than Japanese men in Japan. The Honolulu Heart Program was actually a component of the larger NI-HON-SAN Study. The NI-HON-SAN Study (from the acronyms Nippon, Honolulu, and San Francisco) was initiated in 1965. The populations under investigation included members of the Honolulu Heart Program as well as men of Japanese ancestry born between 1900 and 1919 and residing in Japan and San Francisco.
In the Honolulu Heart Program, 11,148 men were identified of whom 8,006 participated in baseline examinations between 1965 and 1968. The 1965 - 1968 examination included a detailed medical and social history with specific inquiries about smoking, alcohol consumption, diet, and physical activity. A physical examination focussed on the cardiovascular system; laboratory tests included hematocrit, serum cholesterol, triglyceride, uric acid, glucose determination, and urinalysis. A twelve lead electrocardiogram and lung function testing revealed that 301 men had evidence of coronary heart disease and 111 had a stroke. The prevalence of coronary heart disease was slightly higher than in the comparable population in Japan, but the incidence rate during the first two-year period of follow-up was twice as high in Honolulu as in Japan. Stroke prevalence was much higher in Japan than in the Honolulu cohort, with a threefold difference. The Honolulu Japanese men were more obese, ate a more Westernized diet with a higher amount of animal protein, saturated fat, and sucrose and a smaller amount of complex carbohydrates. They had higher levels of serum cholesterol, triglyceride, uric acid, and glucose than Japanese men in Japan. Cigarette smoking was more common in the Japanese cohort, while the proportion of heavy smokers was greater in the Honolulu cohort. Alcohol consumption in the Japanese cohort was twice that of the Honolulu cohort. There were no differences in mean blood pressure or prevalence of hypertension. Repeat examinations were performed near the second and sixth anniversaries of the initial examinations. The six year follow-up data identified 294 new cases of coronary heart disease and 133 new cases of stroke. Between 1970 and 1972 some 2,800 of the cohort were examined and had lipoprotein determinations performed as part of the NHLBI Lipoprotein Phenotyping Project. Survivors of the lipoprotein cohort were reexamined between 1975 and 1978 near the tenth anniversary of their initial examination and again between 1980 and 1982.
In 1985, the program was enlarged to make a comparative analysis of the 12-year incidence of coronary heart disease in the Japanese and Hawaii study cohort of the original NI-HON-SAN Study, to sample 400 offspring of the study cohort ages 45 to 60 years and to complete nutrient indicators for association with blood pressure in a manner consistent with the United States-Japan study of nutrition and blood pressure. Resulting data were compared with a comparable selected group of Japanese men and with the parents of the offspring to examine familial associations. Pulmonary function data were recorded and analyzed for association with other risk factors, respiratory disease, and other major chronic diseases.
Beginning in March 1993 and continuing through December 1994, the National Institute on Aging, with its own funds, investigated aging and dementia among Honolulu Heart Program participants.
Beginning in March 1997, the study was supported by U01HL56274.
DESIGN NARRATIVE:
In this prospective cohort study, the hospital discharge rosters of all general hospitals on the Island of Oahu were reviewed twice yearly as part of the morbidity and mortality surveillance. The appropriate chart materials were abstracted for review by study physicians for evidence of myocardial infarction and stroke. Beginning in 1986, both old and new hospital discharge records were reviewed for the additional endpoints of congestive heart failure, aortic aneurysm, bronchitis, emphysema, asthma, chronic obstructive lung disease, dementia, organic brain syndrome, and Parkinson's disease. Deaths were monitored by following obituary columns as well as reviewing death certificates from the State Health Department. There was daily contact with hospitals to find out about impending autopsies in which study personnel could participate. However, only 20-25 percent of the deaths had protocol autopsies.
The fifth and final complete examination of the surviving cohort concluded in Spring, 1996 under a contract with the National Institute on Aging. While the emphasis of this exam was the investigation of dementia, NHLBI funded the recording of blood pressures and ECGs as well as the continued surveillance for morbidity and mortality. A cooperative agreement extends the surveillance for an additional five years. As part of the close-out phase of the study, frozen blood samples collected since the study's inception have been sent to a repository in Rockville, MD. A review board for screening prospective users of this resource holds quarterly meetings.
As the study group includes both migrants from Japan and Hawaii-born men, there is a spectrum of cultural lifestyles and varying grades of acculturation which are being examined as risk factors for cardiovascular and other chronic diseases. The existing baseline and follow-up examination data and the surveillance information on the incidence of most major diseases provide opportunities for a great variety of research projects concerning the predictors of cardiovascular disease, as well as studies of the broader concepts of health and disease in the aging population. The low out-migration rate and the well-defined sources of medical care have provided an ideal setting for maintaining disease morbidity and mortality surveillance; nearly 100 per cent of hospital discharge episodes have been recorded. As the study participants range in age from 75-95 in 1996, the rates of coronary heart disease, stroke, and other chronic diseases are increasing rapidly and thus are providing a large number of disease endpoints for study. Other Institutes are also currently supporting activities which utilize the original cohort.
Stored sera provide an opportunity to test new ideas and etiologic hypotheses using both prospective and case-control study designs. Protocol autopsy information can now be utilized to examine relationships among risk factors, clinical manifestations of CHD, and stroke and pathological evidence of atherosclerosis.
Beginning in 1997, a cooperative agreement extends the surveillance for an additional five years through February, 2002. As part of the close-out of the study, frozen blood samples collected since the study's inception have been sent to a repository in Rockville, Maryland.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 14 Apr 2016.
- Background: PubMed 7362177Rhoads GG. Hemoglobin A1c reproducibility. Ann Intern Med. 1980 Apr;92(4):574. doi: 10.7326/0003-4819-92-4-574. No abstract available.
- BackgroundMcGee D, Rhoads G, Feinleib M: The Logistic Function. A Model for Assessing Risk of Heart Disease. In Proceedings of the Fourteenth Hawaii International Conference on System Sciences. Edited by B. Shriver et al. Honolulu, Hawaii, University of Hawaii Press pp 722-740, 1981
- Background: PubMed 7287281Blackwelder WC, Kagan A, Gordon T, Rhoads GG. Comparison of methods for diagnosing angina pectoris: the Honolulu heart study. Int J Epidemiol. 1981 Sep;10(3):211-5. doi: 10.1093/ije/10.3.211.
- Background: PubMed 7460234Gordon T, Kagan A, Garcia-Palmieri M, Kannel WB, Zukel WJ, Tillotson J, Sorlie P, Hjortland M. Diet and its relation to coronary heart disease and death in three populations. Circulation. 1981 Mar;63(3):500-15. doi: 10.1161/01.cir.63.3.500.
- Background: PubMed 7246518Kagan A, McGee DL, Yano K, Rhoads GG, Nomura A. Serum cholesterol and mortality in a Japanese-American population: the Honolulu Heart program. Am J Epidemiol. 1981 Jul;114(1):11-20. doi: 10.1093/oxfordjournals.aje.a113157.
- Background: PubMed 7261298Kagan A, Yano K, Rhoads GG, McGee DL. Alcohol and cardiovascular disease: the Hawaiian experience. Circulation. 1981 Sep;64(3 Pt 2):III 27-31.
- Background: PubMed 7068196Reed D, McGee D, Yano K. Biological and social correlates of blood pressure among Japanese men in Hawaii. Hypertension. 1982 May-Jun;4(3):406-14. doi: 10.1161/01.hyp.4.3.406.
- Background: PubMed 7058826Yano K, Kagan A, McGee D, Rhoads GG. Glucose intolerance and nine-year mortality in Japanese men in Hawaii. Am J Med. 1982 Jan;72(1):71-80. doi: 10.1016/0002-9343(82)90580-0.
- Background: PubMed 7124667McGee D, Rhoads G, Hankin J, Yano K, Tillotson J. Within-person variability of nutrient intake in a group of Hawaiian men of Japanese ancestry. Am J Clin Nutr. 1982 Oct;36(4):657-63. doi: 10.1093/ajcn/36.4.657.
- Background: PubMed 7091147Reed D, McGee D, Cohen J, Yano K, Syme SL, Feinleib M. Acculturation and coronary heart disease among Japanese men in Hawaii. Am J Epidemiol. 1982 Jun;115(6):894-905. doi: 10.1093/oxfordjournals.aje.a113377.
- BackgroundKagan A, Yano K, McGee D, Rhoads GG: Epidemiology of Glucose Intolerance in Hawaii Japanese Men. Excerpta Medica. In: Genetic-Enviornmental Interaction in Diabetes Mellitus, Proceedings of the Third Symposium on Diabetes Mellitus in Asia and Oceania; Honolulu Feb 6-7, 1981; ISBN Elsevier North Holland, (International Congress Series No. 549, pp 51-56, 1982
- Background: PubMed 6954343Hulley SB, Rhoads GG. The plasma lipoproteins as risk factors: comparison of electrophoretic and ultracentrifugation results. Metabolism. 1982 Aug;31(8):773-7. doi: 10.1016/0026-0495(82)90074-9.
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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. Curb
Kuakini Medical Center
Jess Curb
Kuakini Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005123, which also lists 245 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 14 Apr 2016.