Nurses' Health Study (Cardiovascular Component)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 121,700
- 主要终点
- Coronary heart disease (CHD)
研究概览
简要总结
To determine the relationships of hormonal, reproductive, dietary, and lifestyle factors, as well as biochemical and genetic factors, with the subsequent risk of coronary heart disease and other cardiovascular events in a cohort of female registered nurses. The current funding cycle involves comprehensive metabolomic profiling of coronary heart disease cases and controls and development of metabolomic risk scores for coronary heart disease.
详细描述
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, diet, and other 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. Blood samples were collected on a subsample of the women between 1989-1990 and stored for analysis of germline DNA and circulating biomarkers.
The cardiovascular component is funded through May 2029.
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. A subset of 32,826 women provided blood samples between 1989 and 1990. Genotyping on 1,186 women (382 with coronary heart disease and 804 matched controls) was performed using Affymetrix 6.0 platform.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •See "Detailed Description"
排除标准
- 未提供
结局指标
主要结局
Coronary heart disease (CHD)
时间窗: The primary outcome measure time frame is first CHD event during person-time of follow-up for each participant from study enrollment through March 2022.
CHD is defined as nonfatal myocardial infarction and death from coronary heart disease. Information on the outcome is assessed by medical record review of events reported on biennial questionnaires or by searches of the National Death Index, and the date of the CHD event or CHD death is ascertained from these sources.
次要结局
未报告次要终点
研究者
JoAnn E. Manson, MD
Principal Investigator
Brigham and Women's Hospital
