Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005174
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Western Collaborative Group Study WCGS 25-Year Follow-up of Cardiovascular Disease Morbidity and Mortality
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3524 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 3154 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 85 years with repeat examinations During the 85 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 21 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 3014 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 2534 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
The WCGS began in 1960 with 3524 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 3154 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 85 years with repeat examinations During the 85 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 21 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 3014 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 2534 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL032795 | NIH | None | httpsreporternihgovquickSearchR01HL032795 |