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Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Noel Bairey Merz, Cedars-Sinai Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600106
First Posted: January 24, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Parke-Davis
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
  Purpose
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.

Condition
Coronary Disease

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Noel Bairey Merz, Cedars-Sinai Medical Center:

Estimated Enrollment: 48
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)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
postmenopausal women
Criteria

Inclusion Criteria:

  • Previously collected samples gathered from the WISE Anc. FemHrt study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600106


Locations
United States, California
Cedars-Sinai Women's Heart Center, 444 S. San Vicente Blvd, Suite 600 &901
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Parke-Davis
Investigators
Principal Investigator: C. Noel Bairey Merz, MD Cedars-Sinai Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00600106     History of Changes
Other Study ID Numbers: 9260
First Submitted: January 11, 2008
First Posted: January 24, 2008
Last Update Posted: October 12, 2017
Last Verified: August 2012

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs