Cardiovascular DiseasesNCT00005174
Western Collaborative Group Study (WCGS): 25-Year Follow-up of Cardiovascular Disease Morbidity and Mortality
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To conduct a 25-year follow-up of the surviving participants in the Western Collaborative Group Study, the first large prospective study of coronary heart disease risk factors to incorporate direct assessment of Type A behavior. 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
- Jul 1985to Jun 1990
- 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 conduct a 25-year follow-up of the surviving participants in the Western Collaborative Group Study, the first large prospective study of coronary heart disease risk factors to incorporate direct assessment of Type A behavior.
Read the detailed description
BACKGROUND:
The WCGS began in 1960 with 3,524 male volunteers who were employed by 11 California companies. Subjects were 39 to 59 years old and free of heart disease as determined by electrocardiogram. After the initial screening, the study population dropped to 3,154 and the number of companies to 10 because of various exclusions. The cohort comprised both blue- and white-collar employees. At baseline the following information was collected: socio-demographic including age, education, marital status, income, occupation; physical and physiological including height, weight, blood pressure, electrocardiogram, and corneal arcus; biochemical including cholesterol and lipoprotein fractions; medical and family history and use of medications; behavioral data including Type A interview, smoking, exercise, and alcohol use. Later surveys added data on anthropometry, triglycerides, Jenkins Activity Survey, and caffeine use. Average follow-up continued for 8.5 years with repeat examinations. During the 8.5 year follow-up, coronary heart disease occurred in 257 of the initially disease-free group, of whom 50 died of coronary heart disease. There were 90 non-coronary disease deaths. Multiple logistic analyses confirmed the roles of blood pressure, serum cholesterol and cigarette smoking as risk factors. The study also found that Type A behavior, as assessed by a Structured Interview, was associated independently with the risk of coronary heart disease and constituted a 2:1 risk.
In 1982, Dr. Richard Brand and Dr. David Ragland at the School of Public Health, University of California at Berkeley, conducted a Mortality Follow-up of the 3,014 WCGS subjects living in 1969. The purpose of the 1982 follow-up was to locate the original participants, determine vital status, and obtain information about the health status of the participants who were still alive, and cause of death of participants who had died between 1969 and 1982. All individuals contacted were asked to participate in the proposed 25-year follow-up physical examination. At that time in 1983 there were 2,534 surviving subjects. All data gathered by the 1982 Mortality Follow-up were used in the 25-year follow-up.
DESIGN NARRATIVE:
The follow-up evaluated the power of cardiovascular disease risk factors, as measured in 1960, to predict coronary heart disease morbidity and mortality over 25 years and to predict stroke. It also evaluated the power of changes in cardiovascular disease risk factors as observed across the seven repeat exams from 1960 to 1969, to predict long-term morbidity and mortality and provided the basis for a potential future follow-up of an aging cohort.
The 25-year follow-up extended the existing database by adding current risk factor status and cardiovascular disease morbidity data collected by physical examinations and personal interviews. The new data included physical, physiological, and biochemical variables, health behavior, medical and family history, and Type A behavior. Existing mortality records were updated and used to determine cause of death and, where possible, the extent of cardiovascular pathology.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, 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 startJul 1985
- Study completionJun 1990
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 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005174
- Sponsor's protocol ID
- 1051
- Other IDs
- R01HL032795
- Status last verified
- Jul 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Fox BH, Ragland DR, Brand RJ, Rosenman RH. Type A behavior and cancer mortality. Theoretical considerations and preliminary data. Ann N Y Acad Sci. 1987;496:620-7. doi: 10.1111/j.1749-6632.1987.tb35822.x.
PubMed 3474993Rosenman RH: An Update on the Type A Behavior Pattern and its Relationship to Coronary Artery Disease. Perspect Lipid Disorders, 5:4-9, 1987
Rosenman RH: Der Einfluss von Angst Oder Angstfreiheit Auf das Kreislaufsystem. In: Nutzinger DO, Pfersmann D, Welan T, and Zapotoczky HG, (Eds.), Herzphobie: Klassifikation, Diagnostik und Therapie. Stuttgart: Ferdinand Enre Verlag, 1987
Rosenman RH. Type A Behavior and Hypertension. In: Julius S, Bassett DR, (Eds.), Handbook of Hypertension, Vol. 9, Behavioral Factors in Hypertension. Elsevier Science, 1987
Rosenman RH, Chesney MA: Behavioral and Pharmacological Modification of Coronary-Prone Type A Behaviors. Directions in Psychiatary. Vol. 4, Lesson 12. New York, Hatherleigh Company, Ltd., 1984
Rosenman RH, Swan GE: Some Reflections on Type A Behavior, Psychiatr Times, 5:Ni.3, March 1988
Carmelli D, Rosenman RH, Swan GE. The Cook and Medley HO scale: a heritability analysis in adult male twins. Psychosom Med. 1988 Mar-Apr;50(2):165-74. doi: 10.1097/00006842-198803000-00006.
PubMed 3375406Rosenman RH, Swan GE: Some Relationships of Contrasting Emotions to Cardiovascular Disorders. Stress Med, 4:27-32, 1988
Swan GE, Carmelli D, Rosenman RH. Psychological correlates of two measures of coronary-prone hostility. Psychosomatics. 1989 Summer;30(3):270-8. doi: 10.1016/S0033-3182(89)72271-4.
PubMed 2762484La Rue A, Swan GE, Carmelli D. Cognition and depression in a cohort of aging men: results from the Western Collaborative Group Study. Psychol Aging. 1995 Mar;10(1):30-3. doi: 10.1037//0882-7974.10.1.30.
PubMed 7779314Palmer CG, Wolkenstein BH, La Rue A, Swan GE, Smalley SL. Commingling analysis of memory performance in elderly men. Genet Epidemiol. 1994;11(5):443-9. doi: 10.1002/gepi.1370110506.
PubMed 7835690Carmelli D, Halpern J, Swan GE, Dame A, McElroy M, Gelb AB, Rosenman RH. 27-year mortality in the Western Collaborative Group Study: construction of risk groups by recursive partitioning. J Clin Epidemiol. 1991;44(12):1341-51. doi: 10.1016/0895-4356(91)90095-q.
PubMed 1753265Swan GE, Dame A, Carmelli D. Involuntary retirement, Type A behavior, and current functioning in elderly men: 27-year follow-up of the Western Collaborative Group Study. Psychol Aging. 1991 Sep;6(3):384-91. doi: 10.1037//0882-7974.6.3.384.
PubMed 1930755Carmelli D, McElroy MR, Rosenman RH. Longitudinal changes in fat distribution in the Western Collaborative Group Study: a 23-year follow-up. Int J Obes. 1991 Jan;15(1):67-74.
PubMed 2010260Swan GE, Carmelli D, Dame A, Rosenman RH, Spielberger CD. The Rationality/Emotional Defensiveness Scale--II. Convergent and discriminant correlational analysis in males and females with and without cancer. J Psychosom Res. 1992 May;36(4):349-59. doi: 10.1016/0022-3999(92)90071-9.
PubMed 1593510
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Western Collaborative Group Study (WCGS): 25-Year Follow-up of Cardiovascular Disease Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT00005174
- Acronym / sponsor ID
- 1051
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1985
- Study completion
- Jun 1990 (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 conduct a 25-year follow-up of the surviving participants in the Western Collaborative Group Study, the first large prospective study of coronary heart disease risk factors to incorporate direct assessment of Type A behavior.
Detailed description
BACKGROUND:
The WCGS began in 1960 with 3,524 male volunteers who were employed by 11 California companies. Subjects were 39 to 59 years old and free of heart disease as determined by electrocardiogram. After the initial screening, the study population dropped to 3,154 and the number of companies to 10 because of various exclusions. The cohort comprised both blue- and white-collar employees. At baseline the following information was collected: socio-demographic including age, education, marital status, income, occupation; physical and physiological including height, weight, blood pressure, electrocardiogram, and corneal arcus; biochemical including cholesterol and lipoprotein fractions; medical and family history and use of medications; behavioral data including Type A interview, smoking, exercise, and alcohol use. Later surveys added data on anthropometry, triglycerides, Jenkins Activity Survey, and caffeine use. Average follow-up continued for 8.5 years with repeat examinations. During the 8.5 year follow-up, coronary heart disease occurred in 257 of the initially disease-free group, of whom 50 died of coronary heart disease. There were 90 non-coronary disease deaths. Multiple logistic analyses confirmed the roles of blood pressure, serum cholesterol and cigarette smoking as risk factors. The study also found that Type A behavior, as assessed by a Structured Interview, was associated independently with the risk of coronary heart disease and constituted a 2:1 risk.
In 1982, Dr. Richard Brand and Dr. David Ragland at the School of Public Health, University of California at Berkeley, conducted a Mortality Follow-up of the 3,014 WCGS subjects living in 1969. The purpose of the 1982 follow-up was to locate the original participants, determine vital status, and obtain information about the health status of the participants who were still alive, and cause of death of participants who had died between 1969 and 1982. All individuals contacted were asked to participate in the proposed 25-year follow-up physical examination. At that time in 1983 there were 2,534 surviving subjects. All data gathered by the 1982 Mortality Follow-up were used in the 25-year follow-up.
DESIGN NARRATIVE:
The follow-up evaluated the power of cardiovascular disease risk factors, as measured in 1960, to predict coronary heart disease morbidity and mortality over 25 years and to predict stroke. It also evaluated the power of changes in cardiovascular disease risk factors as observed across the seven repeat exams from 1960 to 1969, to predict long-term morbidity and mortality and provided the basis for a potential future follow-up of an aging cohort.
The 25-year follow-up extended the existing database by adding current risk factor status and cardiovascular disease morbidity data collected by physical examinations and personal interviews. The new data included physical, physiological, and biochemical variables, health behavior, medical and family history, and Type A behavior. Existing mortality records were updated and used to determine cause of death and, where possible, the extent of cardiovascular pathology.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
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 16 Mar 2016.
- Background: PubMed 3474993Fox BH, Ragland DR, Brand RJ, Rosenman RH. Type A behavior and cancer mortality. Theoretical considerations and preliminary data. Ann N Y Acad Sci. 1987;496:620-7. doi: 10.1111/j.1749-6632.1987.tb35822.x.
- BackgroundRosenman RH: An Update on the Type A Behavior Pattern and its Relationship to Coronary Artery Disease. Perspect Lipid Disorders, 5:4-9, 1987
- BackgroundRosenman RH: Der Einfluss von Angst Oder Angstfreiheit Auf das Kreislaufsystem. In: Nutzinger DO, Pfersmann D, Welan T, and Zapotoczky HG, (Eds.), Herzphobie: Klassifikation, Diagnostik und Therapie. Stuttgart: Ferdinand Enre Verlag, 1987
- BackgroundRosenman RH. Type A Behavior and Hypertension. In: Julius S, Bassett DR, (Eds.), Handbook of Hypertension, Vol. 9, Behavioral Factors in Hypertension. Elsevier Science, 1987
- BackgroundRosenman RH, Chesney MA: Behavioral and Pharmacological Modification of Coronary-Prone Type A Behaviors. Directions in Psychiatary. Vol. 4, Lesson 12. New York, Hatherleigh Company, Ltd., 1984
- BackgroundRosenman RH, Swan GE: Some Reflections on Type A Behavior, Psychiatr Times, 5:Ni.3, March 1988
- Background: PubMed 3375406Carmelli D, Rosenman RH, Swan GE. The Cook and Medley HO scale: a heritability analysis in adult male twins. Psychosom Med. 1988 Mar-Apr;50(2):165-74. doi: 10.1097/00006842-198803000-00006.
- BackgroundRosenman RH, Swan GE: Some Relationships of Contrasting Emotions to Cardiovascular Disorders. Stress Med, 4:27-32, 1988
- Background: PubMed 2762484Swan GE, Carmelli D, Rosenman RH. Psychological correlates of two measures of coronary-prone hostility. Psychosomatics. 1989 Summer;30(3):270-8. doi: 10.1016/S0033-3182(89)72271-4.
- Background: PubMed 7779314La Rue A, Swan GE, Carmelli D. Cognition and depression in a cohort of aging men: results from the Western Collaborative Group Study. Psychol Aging. 1995 Mar;10(1):30-3. doi: 10.1037//0882-7974.10.1.30.
- Background: PubMed 7835690Palmer CG, Wolkenstein BH, La Rue A, Swan GE, Smalley SL. Commingling analysis of memory performance in elderly men. Genet Epidemiol. 1994;11(5):443-9. doi: 10.1002/gepi.1370110506.
- Background: PubMed 1753265Carmelli D, Halpern J, Swan GE, Dame A, McElroy M, Gelb AB, Rosenman RH. 27-year mortality in the Western Collaborative Group Study: construction of risk groups by recursive partitioning. J Clin Epidemiol. 1991;44(12):1341-51. doi: 10.1016/0895-4356(91)90095-q.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 16 Mar 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 NCT00005174, 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 16 Mar 2016.