Nurses' Health Study (Cardiovascular Component)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00005152
First received: May 25, 2000
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Cardiovascular disease [ Time Frame: every 2 years during course of the study ] [ Designated as safety issue: No ]

Enrollment: 121700
Study Start Date: August 1980
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  Hide Detailed Description

Detailed Description:

BACKGROUND:

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.

DESIGN NARRATIVE:

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).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

See "Detailed Description"

Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005152

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: JoAnn E Manson, MD, DrPH Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
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

Additional 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
Study First Received: May 25, 2000
Last Updated: April 4, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 31, 2014