Jump to: Authorized Access | Attribution | Authorized Requests

Study Description

Introduction/Intent

7,875 WHI Extension II Study participants participated in the WHI Long Life Study (LLS). The LLS consisted of a one-time in-person visit (conducted between March 2012 and May 2013) with a blood draw, a brief clinical assessment, and an assessment of functional status.

Primary aims of the blood collection:

  1. Establish a repository of new baseline biospecimen on this cohort
  2. Replenish the WHI biospecimen resource for members of this cohort with a new source of good quality extracted DNA and RNA, plasma, serum, and RBCs for future standard clinical laboratory assays as well as cytokines, proteomics, metabolomics, and other assays that have yet to be imagined
  3. Obtain CBC and metabolic/CVD biomarker data
    1. CVD biomarkers: glucose, insulin, creatinine, CRP, HDL, LDL, triglyceride, cholesterol
    2. CBC: A total of 26 variables were reported, including hematocrit, hemoglobin, WBC/RBC/platelet counts, WBC differential (automated), numerous indices

Materials/Methods

The LLS appointment protocol included a blood draw (~31 ml): 8.5ml EDTA Plasma Separator Tube (PST; catalog # BD362799), 2ml EDTA (catalog # BD367841), 10ml EDTA (catalog # BD366443), 8.5ml Serum Separator Tube (SST; catalog # BD367988), PAXgene (catalog # BD762165)

The PPT and SST were centrifuged by data collectors near the data collection site within two hours of the blood draw. All blood vials and corresponding data forms were shipped via FedEx priority overnight to arrive at the FHCRC Specimen Processing Lab (SPL) the next day. SPL processed the blood vials according to the [LLS Blood Collection Protocol.]. Aliquots were frozen and shipped to the WHI Biorepository (Fisher Bioservices, Rockville, MD) for long term storage at -80 °C.

One of the serum aliquots for each participant was sent from the WHI Biorepository to the University of Minnesota Fairview ARDL Lab for CVD biomarker testing within approximately 6-12 months of the draw date.

The 2ml EDTA vial was delivered to the Seattle Cancer Care Alliance (SCCA) hematology lab soon after receipt at SPL. The SCCA performed the CBC upon receipt.

Results

Of the 7,875 LLS participants, 7,325 (93%) have CVD biomarkers available (glucose, insulin, creatinine, CRP, HDL, LDL, triglyceride, cholesterol) and 7,406 (94%) have CBC data.

The WHI Lab Working Group (LWG) reviewed the blind duplicate data for the CVD Biomarkers and a comparison of the WHI clinic CBC data to the W64 CBC data. Both datasets were approved for release to the WHI investigator's dataset. The data is available [Here] for approved users.

Authorized Access
Publicly Available Data
  Link to other NCBI resources related to this study
Study Inclusion/Exclusion Criteria

WHI Long Life Study - Eligible Population Description

Overview
The goals of the WHI Long Life Study (LLS; also called the in-person visit or home visit) were to develop a resource to support studies of factors associated with healthy aging and to examine the changing levels of intermediate markers of Cardiovascular disease (CVD) risk on subsequent clinical events. The LLS design aimed to maximize the potential scientific opportunities in a cost-efficient manner, taking advantage of existing resources by selecting WHI 2010 - 2015 Extension (Extension II) Medical Records Cohort (MRC) participants who had (or were scheduled to have) data from both genome-wide association studies (GWAS) and baseline CVD biomarker studies.

The target sample size for the WHI LLS was 8,000 participants. Initially, it was estimated that a pool of ~10,000 eligible women would be sufficient to achieve the target sample size. However, the consent rate was lower than expected, so two additional phases of eligible women were added to the pool. Altogether, 14,081 women were eligible. Women were excluded if they resided in an institution (e.g., skilled nursing facility). See Table 1 for an overview of the inclusion criteria for each eligibility Phase and Table 2 for a breakdown of the total eligible population by race and age category. Details of the sampling strategy for the Minority and European Americans included in the eligibility pool follow.

Table 1: Inclusion criteria by Phase

Phase

Date Selected

Requirements

# of ppts

Phase I

10/3/2011

MRC1, GWAS2, baseline CVD biomarkers 3, age ≥72 years old on 1/1/2012

9,930

Phase II

7/3/2012

MRC, GWAS, baseline CVD biomarkers, age ≥ 63 years old on 1/1/2012

2,651

Phase III

9/11/2012

MRC, oversampling of minorities (no age restrictions), European Americans age ≥81 years old on 8/1/2012, GWAS and baseline CVD biomarkers completed subsequent to consent mailing for all Phase III eligibles

1,500

Total

Phase I, Phase II, and Phase III eligible

14,081

1MRC: MRC participants include all African American and Hispanic participants and all Hormone Trial (HT) participants who consented to Extension II.
2GWAS data from one of these WHI studies: SHARe (M5), GARNET (M13), WHIMS+ (W63), or LLS Phase III (W66).
3The CVD biomarkers includes glucose, insulin, CRP, creatinine, triglycerides, total cholesterol, LDL, and HDL.

Table 2. Total eligible population by age (on 1/1/12) and race

Age Category

Black

Hispanic

White

Total

% Eligible by Age

63-71

1,571

778

403

2,752

19.5%

72-75

1,238

548

458

2,244

15.9%

76-80

1,391

479

1,007

2,877

20.4%

81-85

798

334

2,685

3,817

27.1%

86-90

339

109

1,490

1,938

13.8%

>90

96

14

343

453

3.2%

Total

5,433

2,262

6,386

14,081

100%

% Eligible by Race

38.6%

16.1%

45.4%

100%


The LLS Minority Population (Total N=7,695: 5,433 African Americans; 2,262 Hispanics)
The Phases I and II LLS eligible minority population consisted of all living (at the data of selection) WHI Extension II African American and Hispanic participants who were included in the SNP Health Association Resource (SHARe - M5) GWAS project (N=7,356).

The Phase III minority population consisted of all living (at the date of selection) WHI Extension II African American and Hispanic participants who (1) had not already been selected as eligible, (2) had DNA (or buffy coat) and baseline serum available, and (3) were eligible, based on consent, for inclusion in a GWAS project (N = 339).

The LLS European American (EA) Population (Total N=6,386)
The Phases I and II LLS EA eligible population consisted of living members of three sub-groups that together are representative of the entire WHI HT population with regard to age, hysterectomy at baseline, enrollment period (< or ≥ 1996), and rates of myocardial infarction, stroke, venous thrombosis, and diabetes. (See 'Phases I and II EA Sub-group Details', below.)

The Phase III LLS EA eligible population consisted of the oldest living 1,161 EA MRC participants who (1) had not already been selected as eligible, (2) had DNA (or buffy coat) and baseline serum available for testing, and (3) were eligible, based on consent, for inclusion in a GWAS project.

Phases I and II EA Sub-group Details

  1. WHI Memory Study (WHIMS - AS39) EA participants. WHIMS was a large ancillary study designed to study the cognitive effects of hormone therapy. WHIMS participants are HT participants who were over age 65 at baseline (all were 78+ in January 2012). All WHIMS EA participants were eligible for the LLS if they were WHI Extension II and GWAS participants.
    • N = 3,370 [Note: The original count of eligible LLS participants from WHIMS (N=3,389) was reduced due to status changes (e.g., death, no further contact) between the original study population selection on 10/3/2011 and the consent mailings a few months later.]
  2. Genomics and Randomized Trials Network (GARNET - M13) participants who are not in WHIMS. The GARNET study was a case-control GWAS to examine gene-environment interactions in the HT. The study genotyped 4,869 WHI EA participants, including 2,438 cases (myocardial infarction, stroke, venous thrombosis, or diabetes) and 2,431 controls. GARNET participants were selected for LLS to complement the older WHIMS participants so that the age distribution of the LLS EA population would be similar to that of the entire HT EA population.
    • N = 875: All non-WHIMS GARNET controls who continued in WHI Extension II were eligible for the LLS.
    • N = 147: A random sample of non-WHIMS GARNET cases who continued in the WHI Extension II were eligible for the LLS.
  3. Other HT participants (Non-WHIMS, Non-GARNET). An additional group of European American HT participants were randomly selected to round out the representative LLS EA population with respect to age. Of these, the MRC participants were eligible for the WHI LLS.
    • N = 833

Molecular Data
TypeSourcePlatformNumber of Oligos/SNPsSNP Batch IdComment
Whole Genome Genotyping Illumina HumanOmniExpressExome-8v1_A 951117 1059260
Study History

See the main WHI (phs000200) dbGaP page for the WHI timeline.

Selected Publications
Diseases/Traits Related to Study (MeSH terms)
Authorized Data Access Requests
Study Attribution
  • Principal Investigator
    • Garnet Anderson, PhD. Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Funding Sources
    • HHSN268201100046C- WHI Ext II contract, Option B, funded this study. National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.