Full Text View
Tabular View
No Study Results Posted
Related Studies
Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
This study is ongoing, but not recruiting participants.
Study NCT00600106   Information provided by Cedars-Sinai Medical Center
First Received: January 11, 2008   Last Updated: July 30, 2009   History of Changes

January 11, 2008
July 30, 2009
April 2006
December 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00600106 on ClinicalTrials.gov Archive Site
 
 
 
Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
WISE Ancillary Study Data Analyses:Efficacy of Hormone Replacement on Myocardial Ischemia in Postmenopausal Women With Normal/Minimal Coronary Artery Disease: Data Analysis

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.

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.

 
Observational
Cohort, Retrospective
Coronary Disease
Other: No intervention
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
48
January 2012
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previously collected samples gathered from the WISE Anc. FemHrt study.
Female
 
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00600106
C. Noel Bairey Merz, MD/Medical Director, Cedars Sinai Medical Center
9260, 9260
Cedars-Sinai Medical Center
Parke-Davis
Principal Investigator: C. Noel Bairey Merz, MD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP