Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
Information source: Cedars-Sinai Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Disease
Phase: N/A
Status: Active, not recruiting
Sponsored by: Cedars-Sinai Medical Center Official(s) and/or principal investigator(s):
C. Noel Bairey Merz, MD, Principal Investigator, Affiliation: Cedars-Sinai Medical Center
Summary
For the purposes of this study, as a core lab coordinating center, the investigators will be
performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses;
glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab
analyses; brachial artery reactivity test core lab analyses; full study data analyses for
manuscript preparation and the writing and submission and publication of manuscript.
Clinical Details
Official title: WISE Ancillary Study Data Analyses:Efficacy of Hormone Replacement on Myocardial Ischemia in Postmenopausal Women With Normal/Minimal Coronary Artery Disease: Data Analysis
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Detailed description:
Numerous unexpected events occurred during the course of this study led to incomplete and
underpowered results.
Recruitment was closed prematurely due to failure to recruit following publication of the
Women's Health Initiative hormone trial. No conclusions could be drawn due to the power
limitation.
We lost the P31 MR Spectroscopy core lab when WISE MR expert investigators moved to new
institutions from the WISE MR CORE site (at UAB from 1996 to 2001). The planned P31tests
could not be completed with the same protocols used for the initial phase of the WISE.
Initial WISE cohort brachial artery FMD data showed large variability and FMD was only
weakly associated with presence of CAD (Am Heart J 2002; 802-807). Also in WISE women FMD
failed to correlate with directly measured coronary artery endothelial dysfunction in
response to intracoronary acetylcholine. So enthusiasm for FMD testing waned among the WISE
investigators. No conclusions could be drawn due to the power limitations.
We observed that only about 50% of WISE women in the initial cohort could perform the
modified ACIP protocol (used in this substudy for ETT) and even when we excluded
nondiagnostic studies the respective sensitivities and specificities were only 43 and 66%
(Am Heart J 2005;149;527-533). So only 16 and 17 women from the placebo and FemHRT groups,
respectively, completed ETTs at 16 weeks among the 37 randomized and the majority of these
were "indeterminate". Exercise duration, was specified as a secondary outcome measure. No
conclusions could be drawn due to the power limitations.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Previously collected samples gathered from the WISE Anc. FemHrt study.
Locations and Contacts
Cedars-Sinai Women's Heart Center, 444 S. San Vicente Blvd, Suite 600 &901, Los Angeles, California 90048, United States
Additional Information
Starting date: April 2006
Last updated: August 24, 2012
|
