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Nurses' Health Study (Cardiovascular Component)

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v29

  2. Notable

    Primary and study completion dates: Mar 31, 2024 to Jun 1, 2029

    Study description expanded, about 15 words

    Show what changed: Study description
    [...] and circulating biomarkers. The cardiovascular component is currently funded through MarchMay 20222029. DESIGN NARRATIVE: In 1976, 121,700 nurses ages 30-55 compl [...] ete. The study was renewed in FY 2002 to continue follow-up tillthrough March 2007. A major aim of that renewal was to compare the [...] N-oxide, choline, and L-carnitine, of coronary heart disease. The; current funding cycle involvesand comprehensive metabolomic profiling of coronary heart disea [...] opment of metabolomic risk scores for coronary heart disease,. During withthe current funding throughcycle, Marchresearchers 2022will conduct compr [...] [...]

    Study Status, Study Descriptionv28

  3. Minor

    3 amendments

    3 re-verifications since 2022-03-01, no change to tracked fields

    v25-v27

  4. Notable

    Primary and study completion dates: Mar 31, 2022 to Mar 31, 2024

    Study Identification, Study Statusv24

  5. Minor

    3 amendments

    3 re-verifications since 2019-12-09, no change to tracked fields

    v21-v23

Show 19 earlier versions

  1. Notable

    Primary and study completion dates: May 2019 to Mar 31, 2022

    Study description expanded, about 23 words

    Show what changed: Study description
    [...] ed for analysis of germline DNA and circulating biomarkers. The study was formerly supported by R01HL24074. The cardiovascular component is currently funded through MayMarch 20192022. 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 [...] ascertained from independent sources, the study ascertained onan estimated 98.25 percent of deaths. Death certificates were obtained from st [...] rette smoking, menopausal status and current interim use of post-meno [...] [...]

    Study Status, Study Description, Outcome Measures, Referencesv20

  2. Minor

    Study Status

    Re-verified, no change to tracked fields

    v19

  3. Notable

    Primary and study completion dates: Mar 2018 to May 2019

    Primary endpoint revised; Study description revised

    Show what changed: Primary endpoints
    CardiovascularCoronary heart disease (CHD)
    Show what changed: Study description
    [...] 4. The cardiovascular component is currently funded through MarchMay 20182019. DESIGN NARRATIVE: In 1976, 121,700 nurses ages 30-55 compl [...] is for study of gut flora metabolites, with funding through MarchMay 20182019. Genotypes from 1,186 women typed as part of a genome-wide [...]

    Study Status, Study Description, Outcome Measuresv18

  4. Notable

    Primary and study completion dates: Aug 2008 to Mar 2018

    Trial status: Completed to Active, Not Recruiting; Eligibility criteria revised; Study description expanded, about 132 words; and 1 more

    Show all 5 changes in this update
    • Notable Primary and study completion dates: Aug 2008 to Mar 2018
    • Minor Trial status: Completed to Active, Not Recruiting
    • Minor Eligibility criteria revised
      Show what changed
      NoSee eligibility"Detailed criteriaDescription"
    • Minor Study description expanded, about 132 words
      Show what changed
      [...] uestionnaire that included items about their medical history, diet, and other risk factors for cancer. The National Cancer Institute fund [...] naires 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 March 2018. DESIGN NARRATIVE: In 1976, 121,700 nurses ages 30-55 complet [...] vailable on 116,150 or 95.4 percent of the original cohort. A subset of 32,826 wome [...] [...]
    • Minor Publications: 124 to 158
      Show what changed
      Chiuve SE, Cook NR, Shay CM, Rexrode KM, Albert CM, Manson JE, Willett WC, Rimm EB. Lifestyle-based prediction model for the prevention of CVD: the Healthy Heart Score. J Am Heart Assoc. 2014 Nov 14;3(6):e000954. doi: 10.1161/JAHA.114.000954. Qi Q, Kilpelainen TO, Downer MK, Tanaka T, Smith CE, Slui [...]

    Study Identification, Study Status, Study Description, Eligibility, Referencesv17

  5. Minor

    7 amendments

    7 re-verifications since 2014-04-04, no change to tracked fields

    v10-v16

  6. Minor

    Publications: 89 to 124

    Show what changed: Publications
    Wu YC, Hsieh TC, Kao CH, Hsieh CY, Lin TY, Wang CH, Lin YY, Yen KY, Sun SS. Thallium-201 scintigraphy of myxofibrosarcoma. Clin Nucl Med. 2009 Dec;34(12):943-5. doi: 10.1097/RLU.0b013e3181becf2a. No abstract available. Todorov SD, Rachman C, Fourrier A, Dicks LM, van Reenen CA, Prevost H, Dousset X. [...] Manson JE, Rimm EB, Colditz GA, Willett WC, Nathan DM, Arky RA, Rosner B, Hennekens CH, Speizer FE, Stampfer MJ. A prospective study of postmenopausal estrogen therapy and subsequent incidence of non-insulin-dependent diabetes mellitus. Ann Epidemiol. 1992 Sep;2(5):665-73. doi: 10.1016/1047-2797(92) [...]

    Study Status, Referencesv9

  7. Minor

    Enrollment target: 121700

    Study Status, Study Design, Outcome Measuresv8

  8. Notable

    Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI) to Brigham and Women's Hospital

    Collaborators expanded, about 7 words; Study title expanded, about 2 words

    Show what changed: Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
    Show what changed: Study title
    Nurses' Health Study (Cardiovascular Component)

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Eligibility, Contacts/Locations, Referencesv7

  9. Minor

    Trial status: Active, Not Recruiting to Completed

    Primary completion date: Aug 2008; Completion date: Aug 2007 to Aug 2008

    Study Status, Study Design, Eligibilityv6

  10. Minor

    Publications: 88 to 89

    Show what changed: Publications
    Albert CM, Oh K, Whang W, Manson JE, Chae CU, Stampfer MJ, Willett WC, Hu FB. Dietary alpha-linolenic acid intake and risk of sudden cardiac death and coronary heart disease. Circulation. 2005 Nov 22;112(21):3232-8. doi: 10.1161/CIRCULATIONAHA.105.572008.

    Study Status, Referencesv5

  11. Minor

    Publications: 86 to 88

    Show what changed: Publications
    Pai JK, Kraft P, Cannuscio CC, Manson JE, Rexrode KM, Albert CM, Hunter D, Rimm EB. Polymorphisms in the CC-chemokine receptor-2 (CCR2) and -5 (CCR5) genes and risk of coronary heart disease among US women. Atherosclerosis. 2006 May;186(1):132-9. doi: 10.1016/j.atherosclerosis.2005.06.041. Epub 2005 [...]

    Study Status, Referencesv4

  12. Minor

    Publications: 85 to 86

    Show what changed: Publications
    Mukamal KJ, Jensen MK, Gronbaek M, Stampfer MJ, Manson JE, Pischon T, Rimm EB. Drinking frequency, mediating biomarkers, and risk of myocardial infarction in women and men. Circulation. 2005 Sep 6;112(10):1406-13. doi: 10.1161/CIRCULATIONAHA.105.537704. Epub 2005 Aug 29.

    Study Status, Referencesv3

  13. Minor

    Publications: 84 to 85

    Show what changed: Publications
    Shai I, Schulze MB, Manson JE, Rexrode KM, Stampfer MJ, Mantzoros C, Hu FB. A prospective study of soluble tumor necrosis factor-alpha receptor II (sTNF-RII) and risk of coronary heart disease among women with type 2 diabetes. Diabetes Care. 2005 Jun;28(6):1376-82. doi: 10.2337/diacare.28.6.1376.

    Study Status, Referencesv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Brigham and Women's Hospital
436 trials monitored
See 25 trials at risk
Diabetes
4,286 trials monitored
See 187 trials at risk
Stroke
3,289 trials monitored
See 142 trials at risk
Heart Disease
2,136 trials monitored
See 109 trials at risk
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.
Trial Details
NCT Number NCT00005152
Lead Sponsor Brigham and Women's Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Cardiovascular Diseases, Diabetes Mellitus, Coronary Disease, Heart Diseases, Cerebrovascular Accident, Pulmonary Embolism, Angina Pectoris, Myocardial Infarction +2 more
Enrollment 121,700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov