Hormones Inflammation and Thrombosis
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/9/2018 |
| Start Date: | December 2012 |
| End Date: | November 2013 |
The investigators are attempting to determine if the response to aspirin in women is related
to the level of estrogen and progesterone that a woman has.
to the level of estrogen and progesterone that a woman has.
Thrombosis plays a significant role in both acute coronary syndromes (ACS) and early
saphenous vein graft (SVG) failure. Women with coronary heart disease have higher levels of
the inflammatory mediator thromboxane, which is produced by platelets, monocytes, macrophages
and the endothelium. Data show that higher levels of urinary thromboxane (UTXB2) are
associated with SVG failure 6 months after Coronary Artery Bypass Graft (CABG). Women in the
study cohort had higher levels of UTXB2 and higher odds of graft failure when compared to
men. The elevated urinary thromboxane seen in the women in our study cohort may represent a
marker and/or an etiology of thrombosis.
Are the levels of UTXB2 higher in women due to hormonal differences? In a prior pilot study
we investigated whether hormonal levels are associated with changes in urinary thromboxane.
We looked at hormonal and urinary thromboxane levels in 48 postmenopausal and 52
premenopausal women. We found that postmenopausal women had higher levels of UTXB2 than did
premenopausal women (2495 vs. 2299, p=.02) and that in premenopausal women a higher
estrogen/progesterone ratio was associated with the highest levels of urinary thromboxane.
The goal of the current study is to measure the response to seven days of aspirin
administration as it relates to urinary thromboxane levels in pre and post-menopausal women.
With this study we will be able to examine the change in UTXB2 comparing the premenopausal to
post menopausal women. We will also be able to see if the change in UTXB2 in response to
aspirin is affected by hormone levels in the premenopausal women. Lastly this study will
provide reference data for more far-reaching studies exploring how global changes in hormonal
balance (as seen in pregnancy or menopause) or in the level of inflammation (as seen in aging
or with Coronary Artery Disease (CAD) risk factors), affect UTXB2 and platelet
hyperreactivity.
saphenous vein graft (SVG) failure. Women with coronary heart disease have higher levels of
the inflammatory mediator thromboxane, which is produced by platelets, monocytes, macrophages
and the endothelium. Data show that higher levels of urinary thromboxane (UTXB2) are
associated with SVG failure 6 months after Coronary Artery Bypass Graft (CABG). Women in the
study cohort had higher levels of UTXB2 and higher odds of graft failure when compared to
men. The elevated urinary thromboxane seen in the women in our study cohort may represent a
marker and/or an etiology of thrombosis.
Are the levels of UTXB2 higher in women due to hormonal differences? In a prior pilot study
we investigated whether hormonal levels are associated with changes in urinary thromboxane.
We looked at hormonal and urinary thromboxane levels in 48 postmenopausal and 52
premenopausal women. We found that postmenopausal women had higher levels of UTXB2 than did
premenopausal women (2495 vs. 2299, p=.02) and that in premenopausal women a higher
estrogen/progesterone ratio was associated with the highest levels of urinary thromboxane.
The goal of the current study is to measure the response to seven days of aspirin
administration as it relates to urinary thromboxane levels in pre and post-menopausal women.
With this study we will be able to examine the change in UTXB2 comparing the premenopausal to
post menopausal women. We will also be able to see if the change in UTXB2 in response to
aspirin is affected by hormone levels in the premenopausal women. Lastly this study will
provide reference data for more far-reaching studies exploring how global changes in hormonal
balance (as seen in pregnancy or menopause) or in the level of inflammation (as seen in aging
or with Coronary Artery Disease (CAD) risk factors), affect UTXB2 and platelet
hyperreactivity.
Inclusion Criteria:
1. Women age 18-80
2. Signed informed consent.
Exclusion Criteria:
1. History of CAD, Cerebrovascular Accident (CVA) or Peripheral Artery Disease (PAD),
2. On chronic aspirin therapy,
3. On chronic NSAID therapy.
4. Chronic anticoagulation with coumadin,
5. Known thrombocytopenia (Platelet count < 100,000),
6. Pregnancy (self-report),
7. Currently on any type of contraceptive or hormone replacement therapy,
8. Hysterectomy and/or oophorectomy.
9. Recent GI bleeding
10. Bleeding diathesis
11. Chronic Systemic Infection
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Rhondalyn C. McLean, MD
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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