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Nurses' Health Study (Cardiovascular Component)

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ClinicalTrials.gov Identifier: NCT00005152
Recruitment Status : Active, not recruiting
First Posted : May 26, 2000
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital

Brief Summary:
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. Recent aims have focused on inflammatory biomarkers, adipokines, and metabolomics, including gut microbiota metabolites such as trimethylamine N-oxide, choline, and L-carnitine.

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:

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 study was formerly supported by R01HL24074. The cardiovascular component is currently funded through May 2019.

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.

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 follow-up till March 2007. A major aim of that renewal was 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). Subsequent renewal cycles included study of plasma adipokines and metabolomic predictors of CHD. The current funding cycle is for study of gut flora metabolites, with funding through May 2019.

Genotypes from 1,186 women typed as part of a genome-wide association study of coronary heart disease were used to study genetic factors associated with cardiovascular disease and the interplay of genes and diet on cardiovascular risk.


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
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. Coronary heart disease (CHD) [ Time Frame: The primary outcome measure time frame is first CHD event during person-time of follow-up for each participant from study enrollment through April 2019. ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
See "Detailed Description"
Criteria
See "Detailed Description"

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)
Investigators
Principal Investigator: JoAnn E Manson, MD, DrPH Brigham and Women's Hospital

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
Qi Q, Kilpeläinen TO, Downer MK, Tanaka T, Smith CE, Sluijs I, Sonestedt E, Chu AY, Renström F, Lin X, Ängquist LH, Huang J, Liu Z, Li Y, Asif Ali M, Xu M, Ahluwalia TS, Boer JM, Chen P, Daimon M, Eriksson J, Perola M, Friedlander Y, Gao YT, Heppe DH, Holloway JW, Houston DK, Kanoni S, Kim YM, Laaksonen MA, Jääskeläinen T, Lee NR, Lehtimäki T, Lemaitre RN, Lu W, Luben RN, Manichaikul A, Männistö S, Marques-Vidal P, Monda KL, Ngwa JS, Perusse L, van Rooij FJ, Xiang YB, Wen W, Wojczynski MK, Zhu J, Borecki IB, Bouchard C, Cai Q, Cooper C, Dedoussis GV, Deloukas P, Ferrucci L, Forouhi NG, Hansen T, Christiansen L, Hofman A, Johansson I, Jørgensen T, Karasawa S, Khaw KT, Kim MK, Kristiansson K, Li H, Lin X, Liu Y, Lohman KK, Long J, Mikkilä V, Mozaffarian D, North K, Pedersen O, Raitakari O, Rissanen H, Tuomilehto J, van der Schouw YT, Uitterlinden AG, Zillikens MC, Franco OH, Shyong Tai E, Ou Shu X, Siscovick DS, Toft U, Verschuren WM, Vollenweider P, Wareham NJ, Witteman JC, Zheng W, Ridker PM, Kang JH, Liang L, Jensen MK, Curhan GC, Pasquale LR, Hunter DJ, Mohlke KL, Uusitupa M, Cupples LA, Rankinen T, Orho-Melander M, Wang T, Chasman DI, Franks PW, Sørensen TI, Hu FB, Loos RJ, Nettleton JA, Qi L. FTO genetic variants, dietary intake and body mass index: insights from 177,330 individuals. Hum Mol Genet. 2014 Dec 20;23(25):6961-72. doi: 10.1093/hmg/ddu411. Epub 2014 Aug 7.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
McKeown NM, Dashti HS, Ma J, Haslam DE, Kiefte-de Jong JC, Smith CE, Tanaka T, Graff M, Lemaitre RN, Rybin D, Sonestedt E, Frazier-Wood AC, Mook-Kanamori DO, Li Y, Wang CA, Leermakers ETM, Mikkilä V, Young KL, Mukamal KJ, Cupples LA, Schulz CA, Chen TA, Li-Gao R, Huang T, Oddy WH, Raitakari O, Rice K, Meigs JB, Ericson U, Steffen LM, Rosendaal FR, Hofman A, Kähönen M, Psaty BM, Brunkwall L, Uitterlinden AG, Viikari J, Siscovick DS, Seppälä I, North KE, Mozaffarian D, Dupuis J, Orho-Melander M, Rich SS, de Mutsert R, Qi L, Pennell CE, Franco OH, Lehtimäki T, Herman MA. Sugar-sweetened beverage intake associations with fasting glucose and insulin concentrations are not modified by selected genetic variants in a ChREBP-FGF21 pathway: a meta-analysis. Diabetologia. 2018 Feb;61(2):317-330. doi: 10.1007/s00125-017-4475-0. Epub 2017 Nov 2.

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
R01HL034594-28 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018

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