Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 4/17/2018 |
| Start Date: | May 2009 |
| End Date: | March 2018 |
Iron and Atherosclerosis: Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis
The study hypothesis (or theory) is that monthly loss of iron before menopause may reduce
women's risk of hardening of the arteries, or atherosclerosis.
This study uses noninvasive, noncontrast magnetic resonance imaging (MRI) of arteries in
women entering menopause. This will help to determine if there is a correlation between iron
accumulation and hardening of the arteries. In addition, blood levels of hormones will be
measured to help show differences due to hormone levels vs. iron accumulation.
women's risk of hardening of the arteries, or atherosclerosis.
This study uses noninvasive, noncontrast magnetic resonance imaging (MRI) of arteries in
women entering menopause. This will help to determine if there is a correlation between iron
accumulation and hardening of the arteries. In addition, blood levels of hormones will be
measured to help show differences due to hormone levels vs. iron accumulation.
Atherosclerosis, or hardening of the arteries, is the underlying disease responsible for the
vast majority of cardiovascular morbidity and mortality and afflicted over 30 million
Americans in 2005. While the prevalence of atherosclerosis is similar in women and men, women
enjoy a ~5-10 year lag in onset of cardiovascular events compared to men. After menopause, a
state defined by marked reduction in ovarian hormone production, the incidence of events such
as heart attack and stroke caused by atherosclerotic plaque rises up to threefold regardless
of age range. This has prompted numerous investigations of hormone therapy (HT) to lower
cardiovascular risk to premenopausal levels. Therapeutic trials, however, have not realized a
cardiovascular benefit; in fact, initiating HT in large randomized trials did not decrease
and possibly increased cardiovascular risk. Studies of coronary heart disease prevention have
shown mixed results using estrogen alone vs. estrogen plus progestin, while studies of stroke
prevention have consistently shown increased risk with HT. Clearly, different therapeutic
interventions warrant consideration. This proposal seeks to investigate a novel perspective
using longitudinal clinical studies in women at risk of atherosclerosis. The studies involve
a new noncontrast, noninvasive MRI method with blood tests that measure cholesterol, hormone
levels, and inflammation.
vast majority of cardiovascular morbidity and mortality and afflicted over 30 million
Americans in 2005. While the prevalence of atherosclerosis is similar in women and men, women
enjoy a ~5-10 year lag in onset of cardiovascular events compared to men. After menopause, a
state defined by marked reduction in ovarian hormone production, the incidence of events such
as heart attack and stroke caused by atherosclerotic plaque rises up to threefold regardless
of age range. This has prompted numerous investigations of hormone therapy (HT) to lower
cardiovascular risk to premenopausal levels. Therapeutic trials, however, have not realized a
cardiovascular benefit; in fact, initiating HT in large randomized trials did not decrease
and possibly increased cardiovascular risk. Studies of coronary heart disease prevention have
shown mixed results using estrogen alone vs. estrogen plus progestin, while studies of stroke
prevention have consistently shown increased risk with HT. Clearly, different therapeutic
interventions warrant consideration. This proposal seeks to investigate a novel perspective
using longitudinal clinical studies in women at risk of atherosclerosis. The studies involve
a new noncontrast, noninvasive MRI method with blood tests that measure cholesterol, hormone
levels, and inflammation.
Inclusion Criteria:
- women at least 40 yrs of age
- between 1 and 6 menstrual cycles in the past 12 months
- 2 or more of the following risk factors: high blood pressure, diabetes, high
cholesterol, smoking
- no known heart or vascular disease
Exclusion Criteria:
- any known cardiovascular disease such as coronary disease, peripheral vascular
disease, heart failure
- contraindication to MRI scan (e.g. aneurysm clip, iron-containing metal)
NOTE that orthopedic hardware is usually MRI-compatible. We will go over detailed screening
before enrollment.
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