Effects of Hormone Therapy on Vascular Inflammation and Compliance
Estradiol
+ Progesterone
Maladies Occlusives des Artères+2
+ Artériosclérose
+ Maladies Cardiovasculaires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 2000
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.25 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, United StatesOuvrir National Heart, Lung and Blood Institute (NHLBI) dans Google Maps