Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
| Status: | Completed |
|---|---|
| Conditions: | Angina, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/19/2018 |
| Start Date: | December 1999 |
| End Date: | March 2010 |
WISE Ancillary Study Data Analyses: Efficacy of Hormone Replacement on Myocardial Ischemia in Postmenopausal Women With Normal/Minimal Coronary Artery Disease: Data Analysis
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.
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.
See Brief Summary above.
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.
We found this trial at
1
site
8631 W. Third Street
Los Angeles, California 90048
Los Angeles, California 90048
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