Expired Study
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Los Angeles, California 90048


Purpose:

The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. 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. The main trial duration: December 1999 - May 2003. The ancillary data analysis project duration: April 2006 - March 2010.


Study summary:

See Brief Summary above.


Criteria:

Inclusion Criteria - Postmenopausal WISE and nonWISE study participants - Normal/minimally diseased coronary arteries (<50% luminal diameter stenosis in all epicardial coronary arteries) within 36 months of ancillary study entry and no intercurrent MI, PTCA, CABG - Any one (or multiple) of the following criteria suggestive of myocardial ischemia within 36 months of ancillary study entry: 1. Abnormal P-31 magnetic resonance spectroscopy (a fall in quantitative PCr/ATP ratio >15% from control) performed at a WISE or nonWISE site 2. Positive exercise stress test (> or = 1mm horizontal or downsloping, or > or =1.5mm upsloping ST segment depression measured 0.08 msec after the J point), performed and/or interpretated by a WISE or WISE ancillary ancillary trial investigator 3. Reversible stress radionuclide perfusion defect > equivocal and not attributable to breast/imaging artifact. performed as part of the WISE protocol 4. Coronary artery flow reserve <2.25 performed. as part of using the WISE protocol - No contraindications to 12 weeks of FemHRT or hormone replacement therapy - Normal mammogram and pelvic exam (including PAP smear for those with an intact uterus) within 12 months of study entry - Documented normal liver function testing (SGOT) within 3 months of study entry. Exclusion Criteria - Documented myocardial infarction, coronary artery bypass surgery or mechanical revascularization - Systolic blood pressure >200 mmHg or diastolic blood pressure >105 mmHg - LDL-cholesterol >190 mg/dl, triglycerides > or = 300 mg/dl - Clinically significant hepatic or renal dysfunction (SGOT more than 1.2 times normal at baseline, serum creatinine >2) - Uncontrolled diabetes mellitus (FBS > or = 225 mg/dl) or new onset diabetes until stabilized - Clinically significant valvular heart disease, dilated cardiomyopathy, or congestive heart failure (NYHA Class IV or severe Class III) - Currently on hormone replacement therapy and unwilling/unable to withdraw treatment prior to study, (participants are eligible for study entry 4-8 weeks following hormone replacement therapy withdrawal, at the discretion of the WISE ancillary trial Principal Investigator) - Previous breast cancer, mammogram suggestive of cancer, or endometrial cancer without hysterectomy - Abnormal uterine bleeding or abnormal Pap smear (SIL I, II or III, carcinoma in situ, or cancer) - Previous deep venous thrombosis, pulmonary embolism, or other thromboembolic disorder. - Alcoholism or drug abuse - Participation in any other investigational drug or device study Women with elevated diastolic (> or = 90 mm Hg) or systolic (> or = 140 mm Hg) blood pressure, LDL-cholesterol (> or = 160 mg/dl), fasting blood sugar (> or = 130 mg/dl) and women who smoke cigarettes will be told their risk factor levels and referred for evaluation and treatment by their private physician.


NCT ID:

NCT00600106


Primary Contact:

Study Chair
C. Noel Bairey Merz, MD
Cedars-Sinai Medical Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90048
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 23, 2018

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