Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
Information source: Cedars-Sinai Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Disease
Intervention: No intervention (Other)
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, we 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: Cohort, Retrospective
Detailed description:
Coronary endothelial cell dysfunction which results in vasoconstriction is a mechanism
responsible for signs and symptoms of ischemia (decreased blood flow to the heart) in
patients. Preliminary evidence in women suggests that estrogen levels may be involved. Women
have more evidence of a decreased blood supply to the heart muscle even when they have normal
coronary arteries compared to men. This is called Syndrome X. While animal and human work
demonstrates that low estrogen levels make endothelial dysfunction worse, and that estrogen
replacement eliminates this effect, this has not been evaluated in women suffering from
Syndrome X.
The impact of hormone replacement therapy on decreased blood flow to the heart muscle in
female patients with normal coronary arteries (Syndrome X) is unknown.
The primary purpose of the WISE Ancillary FemHRT study (IRB # 2779) was to evaluate the
effect of estrogen replacement therapy with FemHRT in postmenopausal women with Syndrome X
on: 1) inducible myocardial ischemia, measured by P-31 metabolic MR spectroscopy, and 2)
endothelial dysfunction, measured by brachial artery reactivity measurement. Secondary
outcomes of interest were to assess the effect of FemHRT on blood lipids hormone, glucose and
insulin levels.
For the purposes of this study, as a core lab coordinating center, we will be performing the
following analyses on tapes, specimens, and data PREVIOUSLY collected as part of the original
Ancillary WISE FemHRT Study (CSMC IRB#2779): 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. There is no active recruitment of subjects or samples,
specimens or data that is currently and actively being collected. The analyses is
retrospective on previously collected samples gathered from the WISE Anc. FemHrt study.
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
WHC and PRCC, 444 S. San Vicente Blvd, Suite 600 &901, Los Angeles, California 90048, United States
Additional Information
Starting date: April 2006
Ending date: January 2075
Last updated: January 23, 2008
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