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Nurses' Health Study (Cardiovascular Component)

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ClinicalTrials.gov Identifier: NCT00005152
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : July 14, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
To determine the relationships of hormonal factors, a variety of nutrients, diabetes, exercise, and brand of cigarettes smoked with the subsequent risk of coronary heart disease, pulmonary embolism, and stroke in a cohort of female registered nurses.

Condition or disease
Cardiovascular Diseases Diabetes Mellitus Coronary Disease Heart Diseases Cerebrovascular Accident Pulmonary Embolism Angina Pectoris Myocardial Infarction Menopause Postmenopause

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Detailed Description:


The Nurses' Health Study began in 1976, when 121,700 female registered nurses living in eleven states completed a mailed questionnaire that included items about their medical history and risk factors for cancer. The National Cancer Institute funded the first three years of the study and subsequent years on data pertaining to cancer. In 1980 the National Heart, Lung, and Blood Institute began funding the cardiovascular portion of the study. Follow-up questionnaires have been administered every two years subsequently.

The study was formerly supported by R01HL24074.


In 1976, 121,700 nurses ages 30-55 completed and returned the initial Nurses Health Study questionnaire and comprise the Nurses Health Study cohort. The cohort has been followed by means of biennial mailed questionnaires. A total of 109,413 participants responded to the 1978 questionnaire. In addition, 400 women who replied in 1976 stated that they did not wish to continue in the study and 390 women died. In 1980, the first major dietary assessment was added to the questionnaire. In the 1978-1980 interval, there were 624 deaths, 300 women declined further participation, approximately 99,000 completed the full questionnaire including the dietary questionnaire, and another 4,000 completed an abbreviated questionnaire, for a total of about 103,000 responses. In 1982, the overall response was 101,174. The approximately 19,000 living non-respondents were followed by telephone, yielding 71 percent of the non-respondents. Thus, at the end of 1982, current information was available on 116,150 or 95.4 percent of the original cohort.

Deaths in the cohort were usually reported by next-of-kin or postal authorities. At the completion of each mailing cycle, the National Death Index was searched for names of non-respondents who might have died. By comparing deaths ascertained from independent sources, the study ascertained on estimated 98.25 percent of deaths. Death certificates were obtained from state vital statistics departments to confirm all reported deaths. For all death certificates indicating possible cardiovascular disease, permission to obtain further information was requested from family members. Confirmed coronary heart disease death required additional information beyond the death certificate such as autopsy reports, ECG and enzyme changes of myocardial infarction prior to death, classical chest pain immediately prior to death, prior documented myocardial infarction or angina, or prior cardiac catheterization showing severe coronary disease.

Data were collected on date of birth, weight, cigarette smoking, menopausal status and current interim use of post-menopausal hormones. Data were also collected on incident cases of non-fatal myocardial infarction, stroke, pulmonary embolism, and angina pectoris. These items appeared on each questionnaire. In addition, nutritional parameters were assessed by a self-administered semi-quantitative food frequency questionnaire in 1986 and again in 1990.

The study was renewed in 1993 with particular attention given to dietary antioxidants, other nutritional factors, physical activity, regional fat distribution, postmenopausal estrogen and progestin replacement therapy, and biochemical markers including plasma lipids and apoproteins. Follow-up for nonfatal CVD events is over 92 percent for the original 121,700 participants. Fatal CVD events are documented by death certificates and confirmed and classified by review of hospital records, autopsy reports, and interviews with next of kin. Searches of the National Death Index for all nonrespondents ensure the identification of remaining deaths, resulting in mortality follow-up that is more than 98 percent complete.

The study was renewed in FY 2002 to continue followup till March 2007. A major aim is to compare the predictive capability of several biochemical and genetic markers of inflammation and endothelial activation for CHD versus stroke in women: C-reactive protein (CRP), E-selectin, intercellular adhesion molecule-1, endothelin-1, and polymorphisms of the CRP and E-selectin genes. The study also continues the investigation of lifestyle determinants of cardiovascular disease, including hormone replacement therapy (dose, formulation, and duration of use) and alcohol consumption (dose and beverage type), in the full cohort and interactions of these exposures with the above biomarkers and with novel genetic markers (prothrombin and alcohol dehydrogenase-3 gene polymorphisms).

Study Design

Study Type : Observational
Actual Enrollment : 121700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nurses' Health Study (Cardiovascular Component)
Study Start Date : August 1980
Primary Completion Date : August 2008
Study Completion Date : August 2008
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Cardiovascular disease [ Time Frame: every 2 years during course of the study, up to 28 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
See "Detailed Description"
No eligibility criteria
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005152

Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: JoAnn E Manson, MD, DrPH Brigham and Women's Hospital
More Information

Additional Information:
Stampfer MJ, Colditz GA, Willett WC, Rosner B, Speizer FE, Hennekens CH: Coronary Risk Factors in Women - the Nurses' Health Study Experience. In: Proceedings of an NIH Workshop on Coronary Heart Disease in Women, Eaker ED, Packard B, Wenger NK et al (Eds). Haymarket Doyma, Inc. New York, 1987

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JoAnn E. Manson, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00005152     History of Changes
Other Study ID Numbers: 1024
R01HL034594-21 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Pulmonary Embolism
Coronary Disease
Coronary Artery Disease
Angina Pectoris
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Chest Pain