Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005108
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-04-11
Brief Title:
Effects of Hormone Replacement Therapy on Inflammation and Stiffening of Artery Walls
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Hormone Therapy on Vascular Inflammation and Compliance
Status:
COMPLETED
Status Verified Date:
2002-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the effects of hormone replacement therapy estrogen alone or estrogen and progesterone on the walls of arteries in postmenopausal women Inflammation and stiffness of artery walls are two risk factors for atherosclerosis-deposits of fatty substances plaques that can block the vessel causing a heart attack or stroke Estrogen raises the levels of certain substances in the blood that cause vessel inflammation and lowers the levels of others This study will measure the net effects of estrogen on artery wall inflammation and stiffness
Postmenopausal women in good health may participate in this study Volunteers will be screened for eligibility with a complete medical history heart examination and blood tests Participants will be randomly assigned to receive either 1 hormone therapy estradiol 2 mg daily alone for women who have had a hysterectomy or estradiol plus micronized progesterone 200 mg daily for women with an intact uterus or 2 placebo look-alike pills that contain no active drug Women in both groups will take pills for 3 months then no pills for 1 month and then will crossover to the alternate therapy for 3 months ie those in the original placebo group will take hormones and those in the hormone group will take placebo At the end of each 3-month treatment period participants will undergo the following procedures to assess blood vessel inflammation and stiffness
1 Blood tests - 60 cc about 2 ounces of blood will be drawn to measure levels of hormones cholesterol and substances in the blood that indicate inflammation of the vessels
2 Ultrasonography - an ultrasound probe will be applied gently on the neck to image the right and left carotid arteries arteries in the neck that lead to the brain During the procedure the hearts electrical activity will also be monitored with an electrocardiogram and a blood pressure cuff will be wrapped around the arm to obtain blood pressure measurements every 5 minutes
3 Magnetic resonance imaging MRI - Images of the carotid arteries are taken while the volunteer lies on a table in a narrow cylinder containing a magnetic field A padded sensor called an MRI coil is placed over the neck and earplugs are placed in the ears to muffle the loud noise of the machine during scanning During the second half of the exam gadolinium is injected through a catheter thin flexible tube inserted into a vein Gadolinium is a contrast agent that is used to brighten the scan images
Information from this study will increase knowledge about the effects of estrogen on vessel wall inflammation As such it may be used in the future to help guide decisions about chronic hormone replacement therapy in postmenopausal women
Postmenopausal women in good health may participate in this study Volunteers will be screened for eligibility with a complete medical history heart examination and blood tests Participants will be randomly assigned to receive either 1 hormone therapy estradiol 2 mg daily alone for women who have had a hysterectomy or estradiol plus micronized progesterone 200 mg daily for women with an intact uterus or 2 placebo look-alike pills that contain no active drug Women in both groups will take pills for 3 months then no pills for 1 month and then will crossover to the alternate therapy for 3 months ie those in the original placebo group will take hormones and those in the hormone group will take placebo At the end of each 3-month treatment period participants will undergo the following procedures to assess blood vessel inflammation and stiffness
1 Blood tests - 60 cc about 2 ounces of blood will be drawn to measure levels of hormones cholesterol and substances in the blood that indicate inflammation of the vessels
2 Ultrasonography - an ultrasound probe will be applied gently on the neck to image the right and left carotid arteries arteries in the neck that lead to the brain During the procedure the hearts electrical activity will also be monitored with an electrocardiogram and a blood pressure cuff will be wrapped around the arm to obtain blood pressure measurements every 5 minutes
3 Magnetic resonance imaging MRI - Images of the carotid arteries are taken while the volunteer lies on a table in a narrow cylinder containing a magnetic field A padded sensor called an MRI coil is placed over the neck and earplugs are placed in the ears to muffle the loud noise of the machine during scanning During the second half of the exam gadolinium is injected through a catheter thin flexible tube inserted into a vein Gadolinium is a contrast agent that is used to brighten the scan images
Information from this study will increase knowledge about the effects of estrogen on vessel wall inflammation As such it may be used in the future to help guide decisions about chronic hormone replacement therapy in postmenopausal women
Detailed Description:
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 Estrogenprogestin 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 MRIMRA imaging of the carotid arteries and 2 arterial compliance derived from carotid ultrasonography and blood pressure measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-H-0111 | None | None | None |