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Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
This study is ongoing, but not recruiting participants.
First Received: January 11, 2008   Last Updated: July 30, 2009   History of Changes
Sponsor: Cedars-Sinai Medical Center
Collaborator: Parke-Davis
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00600106
  Purpose

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.


Condition Intervention
Coronary Disease
Other: No intervention

Study Type: Observational
Study Design: Cohort, 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 Cedars-Sinai Medical Center:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 48
Study Start Date: April 2006
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: No intervention
    Data analysis
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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cedars Sinai Medical Center ( C. Noel Bairey Merz, MD/Medical Director )
Study ID Numbers: 9260, 9260
Study First Received: January 11, 2008
Last Updated: July 30, 2009
ClinicalTrials.gov Identifier: NCT00600106     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 27, 2009