Western Collaborative Group Study (WCGS): 25-Year Follow-up of Cardiovascular Disease Morbidity and Mortality
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Coronary Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005174
First Posted
May 25, 2000
Last Updated
March 15, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005174
Brief Title
Western Collaborative Group Study (WCGS): 25-Year Follow-up of Cardiovascular Disease Morbidity and Mortality
Study Type
Observational
2. Study Status
Record Verification Date
July 2000
Overall Recruitment Status
Completed
Study Start Date
July 1985 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1990 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Cerebrovascular Accident
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
3474993
Citation
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.
Results Reference
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Citation
Rosenman RH: An Update on the Type A Behavior Pattern and its Relationship to Coronary Artery Disease. Perspect Lipid Disorders, 5:4-9, 1987
Results Reference
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Citation
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
Results Reference
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Citation
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
Results Reference
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Citation
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
Results Reference
background
Citation
Rosenman RH, Swan GE: Some Reflections on Type A Behavior, Psychiatr Times, 5:Ni.3, March 1988
Results Reference
background
PubMed Identifier
3375406
Citation
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.
Results Reference
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Citation
Rosenman RH, Swan GE: Some Relationships of Contrasting Emotions to Cardiovascular Disorders. Stress Med, 4:27-32, 1988
Results Reference
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PubMed Identifier
2762484
Citation
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.
Results Reference
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PubMed Identifier
7779314
Citation
La 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.
Results Reference
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PubMed Identifier
7835690
Citation
Palmer 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.
Results Reference
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PubMed Identifier
1753265
Citation
Carmelli 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.
Results Reference
background
PubMed Identifier
1930755
Citation
Swan 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.
Results Reference
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PubMed Identifier
2010260
Citation
Carmelli 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.
Results Reference
background
PubMed Identifier
1593510
Citation
Swan 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.
Results Reference
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Western Collaborative Group Study (WCGS): 25-Year Follow-up of Cardiovascular Disease Morbidity and Mortality
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