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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005174
Other study ID # 1051
Secondary ID R01HL032795
Status Completed
Phase N/A
First received May 25, 2000
Last updated March 15, 2016
Start date July 1985
Est. completion date June 1990

Study information

Verified date July 2000
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date June 1990
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (15)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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

Rosenman RH, Swan GE: Some Reflections on Type A Behavior, Psychiatr Times, 5:Ni.3, March 1988

Rosenman RH, Swan GE: Some Relationships of Contrasting Emotions to Cardiovascular Disorders. Stress Med, 4:27-32, 1988

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: 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

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. — View Citation

Swan GE, Carmelli D, Rosenman RH. Psychological correlates of two measures of coronary-prone hostility. Psychosomatics. 1989 Summer;30(3):270-8. — View 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. — View Citation

* Note: There are 15 references in allClick here to view all references

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