Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|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 Start Date:||April 2006|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600106
|United States, California|
|Cedars-Sinai Women's Heart Center, 444 S. San Vicente Blvd, Suite 600 &901|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||C. Noel Bairey Merz, MD||Cedars-Sinai Medical Center|