Effects of Hormone Therapy on Vascular Inflammation and Compliance
Estradiol
+ Progesterone
Arterial Occlusive Diseases+2
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: April 1, 2000
Actual date on which the first participant was enrolled.Vascular inflammation plays an important role in the pathogenesis of atherosclerosis and may contribute to stiffening of arteries that increases the risk of myocardial infarction and stroke. Accordingly, therapies that reduce vascular inflammation may reduce cardiovascular risk. The effect of estrogen therapy on serum markers of inflammation in postmenopausal women is divergent: Estrogen increases the levels of C-reactive protein, interleukin-6, and matrix metalloproteinase-9 ( MMP-9), but decreases levels of the soluble cell adhesion molecules ICAM-1, VCAM-1 and E-selectin. MMP-9 is secreted by macrophages and cytokine-activated smooth muscle cells, with increased expression in the vicinity of atherosclerotic plaques. Although activation of MMP-9 by estrogen could be deleterious in women with coronary artery disease by digesting the fibrous caps of vulnerable plaques and provoking thrombosis (consistent with the Heart and Estrogen/progestin Replacement Study), activation of MMP-9 in healthy postmenopausal women may remove excess matrix proteins that contribute to arterial stiffness (reduced compliance), thus reducing cardiovascular risk (consistent with the Nurses' Health Study). Reduction of levels of cell adhesion molecules might protect against new plaque development in both groups of women. The purposes of this protocol are to determine the net effects of estrogen therapy on 1) vascular inflammation in postmenopausal women, using MRI/MRA imaging of the carotid arteries, and 2) arterial compliance, derived from carotid ultrasonography and blood pressure measurements.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Ability to comprehend or unwillingness to sign the consent form. No use of estrogen therapy within 2 months of this study. No history of breast cancer, uterine cancer, or estrogen-dependent tumor. No history of deep vein thrombosis or pulmonary embolus. No cigarette smokers (within 2 years). No diabetes mellitus (FBS greater than 120 mg/dL). Triglycerides less than 400 mg/dL. Blood pressure less than 160/90 without antihypertensive therapy. No history of coronary artery disease. No history of carotid artery disease or stroke. No history of pancreatitis. No history of claustrophobia. No history of involuntary motion disorder. Specific MRI exclusion criteria (i.e., no pacemaker, no cochlear implants, no AICD, no internal infusion pump, no metal implants or clips in field of view). No systemic inflammatory disorder (e.g., rheumatoid arthritis, periarteritis nodosa, systemic lupus erythromatosus, temporal arteritis). Must not have a need for chronic aspirin or NSAID therapy.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, United StatesOpen National Heart, Lung and Blood Institute (NHLBI) in Google Maps