Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study

Cedars-Sinai Medical Center

Status

Completed

Conditions

Myocardial Ischemia

Treatments

Drug: Placebo

Drug: 1/10 NA/EE

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00600106

9260

IRB#0505140 (Other Identifier)

Details and patient eligibility

About

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.

Full description

See Brief Summary above.

Enrollment

37 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.