Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Cedars-Sinai Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Parke-Davis
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00600106
First received: January 11, 2008
Last updated: August 24, 2012
Last verified: August 2012

January 11, 2008
August 24, 2012
April 2006
January 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00600106 on ClinicalTrials.gov Archive Site
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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, 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

postmenopausal women

Coronary Disease
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Merz CN, Olson MB, McClure C, Yang YC, Symons J, Sopko G, Kelsey SF, Handberg E, Johnson BD, Cooper-DeHoff RM, Sharaf B, Rogers WJ, Pepine CJ. A randomized controlled trial of low-dose hormone therapy on myocardial ischemia in postmenopausal women with no obstructive coronary artery disease: results from the National Institutes of Health/National Heart, Lung, and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation (WISE). Am Heart J. 2010 Jun;159(6):987.e1-7. doi: 10.1016/j.ahj.2010.03.024.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previously collected samples gathered from the WISE Anc. FemHrt study.
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00600106
9260, 9260
Yes
Noel Bairey Merz, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Parke-Davis
Principal Investigator: C. Noel Bairey Merz, MD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
August 2012

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