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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Iron and Atherosclerosis: Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis|
- vessel wall changes over time that precede plaque buildup [ Time Frame: baseline, 1-year follow-up and 2-year follow-up ] [ Designated as safety issue: No ]
- development of cardiovascular disease [ Time Frame: annually for 4 years after baseline visit ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Women at the beginning stages of menopause
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921011
|United States, Ohio|
|The Ohio State Univeristy Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Subha V Raman, MD||Ohio State University|