Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborators: Allegheny University; Johns Hopkins University; Parke-Davis; University of Alabama at Birmingham; University of Florida; University of Pittsburgh
• Treatments: Hormones

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.