Cardiovascular DiseasesNCT00005140
Epidemiology of Cardiovascular and Non-Cardiovascular Risk In Chicago
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To continue the comprehensive research program on the epidemiology of cardiovascular and other major chronic diseases, including cancer and diabetes, in four Chicago population cohorts. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1977to Jul 2006
- 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 continue the comprehensive research program on the epidemiology of cardiovascular and other major chronic diseases, including cancer and diabetes, in four Chicago population cohorts. The four cohorts include the Chicago Heart Association Detection Project in Industry cohort, the Peoples Gas Company cohort first examined in 1958-1959, the Peoples Gas Company cohort first examined in 1959-1962, and the Western Electric Company cohort.
Read the detailed description
BACKGROUND:
Over the last forty years, epidemiologic studies have made basic contributions to knowledge of the etiology and natural history of the chronic diseases -- cardiovascular diseases, diabetes, and cancers. Findings from the epidemiologic studies have provided practical foundations for the development of prevention and control programs to improve life styles and to control high blood pressure by drugs, when indicated. These developments and their impact on life styles and risk factors have probably contributed to the marked decline in mortality rates from coronary heart disease, stroke, all cardiovascular disease, and all causes throughout the 1970s and 1980s.
The four epidemiologic studies have as their foundation the major contributions of the earlier 'first generation' epidemiological studies including the Albany Civil Servant Study, the Charleston Study, the Framingham Heart Study, the Tecumseh Study and others. The significance of these studies lies in their potential for elucidating key 'second generation' issues in the epidemiology of the major cardiovascular and non-cardiovascular chronic diseases.
DESIGN NARRATIVE:
Chicago Heart Association Detection Project in Industry: Employees of 85 firms in the greater Chicago area were screened between the Fall of 1967 to early 1973. The total labor force among these companies was over 75,000 persons. The volunteer rate for the screening was 55 percent. All employees were encouraged to participate irrespective of job type or shift worked. At each employment site data were collected on smoking habits, previous medical diagnosis, current treatments for hypertension, heart disease and diabetes, height and weight, age, sex, race, heart rate.
Peoples Gas Company: All data on the two cohorts were collected as part of the periodic medical examination program for all employees in the Medical Department of the Company by its full-time staff of physicians. Data were collected on age, race, height, weight, blood pressure, serum cholesterol, smoking history, heart rate, resting ECG, medical and family history, alcohol and coffee and tea consumption, education, military service, occupation, physical activity, diet, and glucose and serum uric acid levels. Repeat exams were scheduled yearly for men 50-59, every two years for men 40-49, and every four years for men 25-39.
Western Electric Company: This longitudinal study of coronary heart disease was initiated in 1957 at the Hawthorne Works of the Western Electric Company in Chicago. The male subjects were free of coronary heart disease at baseline. The medical history and physical examination were modeled after the Framingham Heart Study. Data were collected on diet, physical activity, electrocardiogram, blood hemoglobin and blood cholesterol levels, body fatness, blood pressure, height, weight, lipoprotein lipase, glucose level, and smoking.
The study was renewed in FY 1992 and again in FY 1998. The 1998 renewal used data and analyses from the four cohorts. It focused on six specific aims: factors influencing coronary heart disease-cardiovascular disease risk long-term in young adult women and men (ages 18 to 39 at baseline); factors influencing coronary heart disease-cardiovascular disease risk long-term in African-American women and men; factors influencing coronary heart disease-cardiovascular disease risk during both earlier and later follow-up (first 15 years and beyond 15 years of follow-up); impact of baseline low risk status on long-term risk of mortality from coronary heart disease, cardiovascular disease, non-cardiovascular disease, and all causes; relationship of habitual intake of multiple food groups to 10 year change in serum cholesterol, blood pressure, weight, and to 30-year risks of death from coronary heart disease, cardiovascular disease, cancers, and all causes; differences in risk factors impact between groups based on sex, race, age, or risk factor status.
The study has been extended through July 2005 and uses data and analyses from the Chicago Heart Association Detection Project in Industry cohort. The study focuses on three specific aims: factors influencing coronary heart disease and cardiovascular disease risk long-term in young adult women (ages 18-39 at baseline); factors influencing coronary heart disease and cardiovascular disease risk long-term in young adult and middle-aged African American men and women; and the impact of baseline "low risk" status on long-term mortality from coronary heart disease, cardiovascular disease, non-cardiovascular disease, and all causes in young adult women (ages 18-39), including African-American and white women.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Cerebrovascular Disorders, Diabetes Mellitus, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Cerebrovascular Disorders, Diabetes Mellitus, Hypertension, Stroke
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 startSep 1977
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (131)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
- Philip Greenland, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005140
- Sponsor's protocol ID
- 1011
- Other IDs
- R01HL021010
- Status last verified
- Jan 2008
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
LeGrady D, Dyer AR, Shekelle RB, Stamler J, Liu K, Paul O, Lepper M, Shryock AM. Coffee consumption and mortality in the Chicago Western Electric Company Study. Am J Epidemiol. 1987 Nov;126(5):803-12. doi: 10.1093/oxfordjournals.aje.a114717.
PubMed 3661528Liao Y, Liu K, Dyer A, Schoenberger JA, Shekelle RB, Collette P, Stamler J. Sex differential in the relationship of electrocardiographic ST-T abnormalities to risk of coronary death: 11.5 year follow-up findings of the Chicago Heart Association Detection Project in Industry. Circulation. 1987 Feb;75(2):347-52. doi: 10.1161/01.cir.75.2.347.
PubMed 3492312Liu K. Measurement error and its impact on partial correlation and multiple linear regression analyses. Am J Epidemiol. 1988 Apr;127(4):864-74. doi: 10.1093/oxfordjournals.aje.a114870.
PubMed 3354551Clay CM, Dyer AR, Liu K, Stamler J, Shekelle RB, Berkson DM, Paul O, Schoenberger JA, Lepper M, Lindberg HA, et al. Education, smoking and non-cardiovascular mortality: findings in three Chicago epidemiological studies. Int J Epidemiol. 1988 Jun;17(2):341-7. doi: 10.1093/ije/17.2.341.
PubMed 3403129Levine W, Dyer AR, Shekelle RB, Schoenberger JA, Stamler J. Serum uric acid and 11.5-year mortality of middle-aged women: findings of the Chicago Heart Association Detection Project in Industry. J Clin Epidemiol. 1989;42(3):257-67. doi: 10.1016/0895-4356(89)90061-9.
PubMed 2709083Levine W, Dyer AR, Shekelle RB, Schoenberger JA, Stamler J. Post-load plasma glucose and cancer mortality in middle-aged men and women. 12-year follow-up findings of the Chicago Heart Association Detection Project in Industry. Am J Epidemiol. 1990 Feb;131(2):254-62. doi: 10.1093/oxfordjournals.aje.a115495.
PubMed 2296978Dyer AR, Stamler J, Shekelle RB. Serum cholesterol and mortality from coronary heart disease in young, middle-aged, and older men and women from three Chicago epidemiologic studies. Ann Epidemiol. 1992 Jan-Mar;2(1-2):51-7. doi: 10.1016/1047-2797(92)90037-q.
PubMed 1342265Vaccaro O, Ruth KJ, Stamler J. Relationship of postload plasma glucose to mortality with 19-yr follow-up. Comparison of one versus two plasma glucose measurements in the Chicago Peoples Gas Company Study. Diabetes Care. 1992 Oct;15(10):1328-34. doi: 10.2337/diacare.15.10.1328.
PubMed 1425098Shekelle RB, Tangney CC, Rossof AH, Stamler J. Serum cholesterol, beta-carotene, and risk of lung cancer. Epidemiology. 1992 Jul;3(4):282-7. doi: 10.1097/00001648-199207000-00003.
PubMed 1637892Goff DC Jr, Shekelle RB, Katan MB, Gotto AM Jr, Stamler J. Does body fatness modify the association between dietary cholesterol and risk of coronary death? Results from the Chicago Western Electric Study. Arterioscler Thromb. 1992 Jul;12(7):755-61. doi: 10.1161/01.atv.12.7.755.
PubMed 1616901Stamler J. Diet and coronary heart disease. Biometrics. 1982 Mar;38 Suppl:95-118.
PubMed 7046825Liu K, Stamler J, Stamler R, Cooper R, Shekelle RB, Schoenberger JA, Berkson DM, Lindberg HA, Marquardt J, Stevens E, Tokich T. Methodological problems in characterizing an individual's plasma glucose level. J Chronic Dis. 1982;35(6):475-85. doi: 10.1016/0021-9681(82)90062-5.
PubMed 7076788Circulating cholesterol level and risk of death from cancer in men aged 40 to 69 years. Experience of an international collaborative group. JAMA. 1982 Dec 3;248(21):2853-9. doi: 10.1001/jama.1982.03330210035031.
PubMed 7143647Liu K, Cedres LB, Stamler J, Dyer A, Stamler R, Nanas S, Berkson DM, Paul O, Lepper M, Lindberg HA, Marquardt J, Stevens E, Schoenberger JA, Shekelle RB, Collette P, Shekelle S, Garside D. Relationship of education to major risk factors and death from coronary heart disease, cardiovascular diseases and all causes, Findings of three Chicago epidemiologic studies. Circulation. 1982 Dec;66(6):1308-14. doi: 10.1161/01.cir.66.6.1308. No abstract available.
PubMed 6814786Dyer AR, Stamler J, Shekelle RB, Schoenberger JA, Stamler R, Shekelle S, Berkson DM, Paul O, Lepper MH, Lindberg HA. Relative weight and blood pressure in four Chicago epidemiologic studies. J Chronic Dis. 1982;35(12):897-908. doi: 10.1016/0021-9681(82)90121-7.
PubMed 7174772
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Cardiovascular and Non-Cardiovascular Risk In Chicago
- ClinicalTrials.gov ID
- NCT00005140
- Acronym / sponsor ID
- 1011
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Cerebrovascular Disorders, Diabetes Mellitus, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1977
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- 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 continue the comprehensive research program on the epidemiology of cardiovascular and other major chronic diseases, including cancer and diabetes, in four Chicago population cohorts. The four cohorts include the Chicago Heart Association Detection Project in Industry cohort, the Peoples Gas Company cohort first examined in 1958-1959, the Peoples Gas Company cohort first examined in 1959-1962, and the Western Electric Company cohort.
Detailed description
BACKGROUND:
Over the last forty years, epidemiologic studies have made basic contributions to knowledge of the etiology and natural history of the chronic diseases -- cardiovascular diseases, diabetes, and cancers. Findings from the epidemiologic studies have provided practical foundations for the development of prevention and control programs to improve life styles and to control high blood pressure by drugs, when indicated. These developments and their impact on life styles and risk factors have probably contributed to the marked decline in mortality rates from coronary heart disease, stroke, all cardiovascular disease, and all causes throughout the 1970s and 1980s.
The four epidemiologic studies have as their foundation the major contributions of the earlier 'first generation' epidemiological studies including the Albany Civil Servant Study, the Charleston Study, the Framingham Heart Study, the Tecumseh Study and others. The significance of these studies lies in their potential for elucidating key 'second generation' issues in the epidemiology of the major cardiovascular and non-cardiovascular chronic diseases.
DESIGN NARRATIVE:
Chicago Heart Association Detection Project in Industry: Employees of 85 firms in the greater Chicago area were screened between the Fall of 1967 to early 1973. The total labor force among these companies was over 75,000 persons. The volunteer rate for the screening was 55 percent. All employees were encouraged to participate irrespective of job type or shift worked. At each employment site data were collected on smoking habits, previous medical diagnosis, current treatments for hypertension, heart disease and diabetes, height and weight, age, sex, race, heart rate.
Peoples Gas Company: All data on the two cohorts were collected as part of the periodic medical examination program for all employees in the Medical Department of the Company by its full-time staff of physicians. Data were collected on age, race, height, weight, blood pressure, serum cholesterol, smoking history, heart rate, resting ECG, medical and family history, alcohol and coffee and tea consumption, education, military service, occupation, physical activity, diet, and glucose and serum uric acid levels. Repeat exams were scheduled yearly for men 50-59, every two years for men 40-49, and every four years for men 25-39.
Western Electric Company: This longitudinal study of coronary heart disease was initiated in 1957 at the Hawthorne Works of the Western Electric Company in Chicago. The male subjects were free of coronary heart disease at baseline. The medical history and physical examination were modeled after the Framingham Heart Study. Data were collected on diet, physical activity, electrocardiogram, blood hemoglobin and blood cholesterol levels, body fatness, blood pressure, height, weight, lipoprotein lipase, glucose level, and smoking.
The study was renewed in FY 1992 and again in FY 1998. The 1998 renewal used data and analyses from the four cohorts. It focused on six specific aims: factors influencing coronary heart disease-cardiovascular disease risk long-term in young adult women and men (ages 18 to 39 at baseline); factors influencing coronary heart disease-cardiovascular disease risk long-term in African-American women and men; factors influencing coronary heart disease-cardiovascular disease risk during both earlier and later follow-up (first 15 years and beyond 15 years of follow-up); impact of baseline low risk status on long-term risk of mortality from coronary heart disease, cardiovascular disease, non-cardiovascular disease, and all causes; relationship of habitual intake of multiple food groups to 10 year change in serum cholesterol, blood pressure, weight, and to 30-year risks of death from coronary heart disease, cardiovascular disease, cancers, and all causes; differences in risk factors impact between groups based on sex, race, age, or risk factor status.
The study has been extended through July 2005 and uses data and analyses from the Chicago Heart Association Detection Project in Industry cohort. The study focuses on three specific aims: factors influencing coronary heart disease and cardiovascular disease risk long-term in young adult women (ages 18-39 at baseline); factors influencing coronary heart disease and cardiovascular disease risk long-term in young adult and middle-aged African American men and women; and the impact of baseline "low risk" status on long-term mortality from coronary heart disease, cardiovascular disease, non-cardiovascular disease, and all causes in young adult women (ages 18-39), including African-American and white women.
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 18 Feb 2016.
- Background: PubMed 3661528LeGrady D, Dyer AR, Shekelle RB, Stamler J, Liu K, Paul O, Lepper M, Shryock AM. Coffee consumption and mortality in the Chicago Western Electric Company Study. Am J Epidemiol. 1987 Nov;126(5):803-12. doi: 10.1093/oxfordjournals.aje.a114717.
- Background: PubMed 3492312Liao Y, Liu K, Dyer A, Schoenberger JA, Shekelle RB, Collette P, Stamler J. Sex differential in the relationship of electrocardiographic ST-T abnormalities to risk of coronary death: 11.5 year follow-up findings of the Chicago Heart Association Detection Project in Industry. Circulation. 1987 Feb;75(2):347-52. doi: 10.1161/01.cir.75.2.347.
- Background: PubMed 3354551Liu K. Measurement error and its impact on partial correlation and multiple linear regression analyses. Am J Epidemiol. 1988 Apr;127(4):864-74. doi: 10.1093/oxfordjournals.aje.a114870.
- Background: PubMed 3403129Clay CM, Dyer AR, Liu K, Stamler J, Shekelle RB, Berkson DM, Paul O, Schoenberger JA, Lepper M, Lindberg HA, et al. Education, smoking and non-cardiovascular mortality: findings in three Chicago epidemiological studies. Int J Epidemiol. 1988 Jun;17(2):341-7. doi: 10.1093/ije/17.2.341.
- Background: PubMed 2709083Levine W, Dyer AR, Shekelle RB, Schoenberger JA, Stamler J. Serum uric acid and 11.5-year mortality of middle-aged women: findings of the Chicago Heart Association Detection Project in Industry. J Clin Epidemiol. 1989;42(3):257-67. doi: 10.1016/0895-4356(89)90061-9.
- Background: PubMed 2296978Levine W, Dyer AR, Shekelle RB, Schoenberger JA, Stamler J. Post-load plasma glucose and cancer mortality in middle-aged men and women. 12-year follow-up findings of the Chicago Heart Association Detection Project in Industry. Am J Epidemiol. 1990 Feb;131(2):254-62. doi: 10.1093/oxfordjournals.aje.a115495.
- Background: PubMed 1342265Dyer AR, Stamler J, Shekelle RB. Serum cholesterol and mortality from coronary heart disease in young, middle-aged, and older men and women from three Chicago epidemiologic studies. Ann Epidemiol. 1992 Jan-Mar;2(1-2):51-7. doi: 10.1016/1047-2797(92)90037-q.
- Background: PubMed 1425098Vaccaro O, Ruth KJ, Stamler J. Relationship of postload plasma glucose to mortality with 19-yr follow-up. Comparison of one versus two plasma glucose measurements in the Chicago Peoples Gas Company Study. Diabetes Care. 1992 Oct;15(10):1328-34. doi: 10.2337/diacare.15.10.1328.
- Background: PubMed 1637892Shekelle RB, Tangney CC, Rossof AH, Stamler J. Serum cholesterol, beta-carotene, and risk of lung cancer. Epidemiology. 1992 Jul;3(4):282-7. doi: 10.1097/00001648-199207000-00003.
- Background: PubMed 1616901Goff DC Jr, Shekelle RB, Katan MB, Gotto AM Jr, Stamler J. Does body fatness modify the association between dietary cholesterol and risk of coronary death? Results from the Chicago Western Electric Study. Arterioscler Thromb. 1992 Jul;12(7):755-61. doi: 10.1161/01.atv.12.7.755.
- Background: PubMed 7046825Stamler J. Diet and coronary heart disease. Biometrics. 1982 Mar;38 Suppl:95-118.
- Background: PubMed 7076788Liu K, Stamler J, Stamler R, Cooper R, Shekelle RB, Schoenberger JA, Berkson DM, Lindberg HA, Marquardt J, Stevens E, Tokich T. Methodological problems in characterizing an individual's plasma glucose level. J Chronic Dis. 1982;35(6):475-85. doi: 10.1016/0021-9681(82)90062-5.
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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.
Philip Greenland
Northwestern University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, 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 18 Feb 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 NCT00005140, which also lists 131 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 18 Feb 2016.