Atherosclerosis Research Unit
EARLY VERSUS LATE
INTERVENTION TRIAL
WITH ESTRADIOL
(ELITE)
(Principal Investigator: Howard N. Hodis, M.D.)
Why Study the Effects of Estradiol on Atherosclerosis?
“We believe that based on all the data now available, the benefits of hormone therapy outweigh the risks.” (Philips LS, Langer RD. Fert Steril 2005;83:558-566).As this recently published conclusion from two WHI investigators indicates, the issues concerning hormone therapy and women’s health are far from settled. Lack of sufficient information has created a void and overgeneralization of this limited information has generated confusion and uncertainty for women and health care providers.
Estradiol reduces the progression of atherosclerosis, an early precursor to heart disease in healthy postmenopausal women. Additional studies such as the WHI suggest that the effects of estrogen may depend upon when estrogen therapy is started in relation to the time when a woman enters menopause. As such, the National Institutes of Health (NIH) has funded ELITE, a new study designed to answer one of the most important questions concerning women’s health -- whether the beneficial effects of estrogen depends on when a postmenopausal women starts estrogen therapy.
Estrogen therapy remains a promising approach for the prevention of coronary heart disease in postmenopausal women who have not yet developed symptoms of heart disease. It is important to understand the effects of estrogen therapy on atherosclerosis so that women as well as physicians can decide if this form of therapy can be used to reduce atherosclerosis and risk of coronary heart disease in women.
What is Atherosclerosis?
Atherosclerosis, accumulation of cholesterol-containing plaques in the arteries, is the foremost cause of death in the United States today. It can block circulation of blood to the heart and brain, causing a heart attack, angina (chest pain), and stroke. This condition, known as cardiovascular disease, is responsible for 750,000 deaths in the United States each year.How Are Women Affected?
Cardiovascular disease is the leading cause of death in women. Atherosclerosis, the cause of cardiovascular disease, accounts for more than 485,000 heart attacks each year in American women. Before menopause, women have a very low risk of suffering from a cardiovascular event possibly protected by estrogen. More than 90% of deaths due to atherosclerosis occur after menopause when a women's production of estrogen diminishes.
To Be Eligible to Participate You Must:By contacting our clinic, you may have the opportunity to participate. In so doing, you may receive several important health benefits.
What is Expected of the Volunteer Participant?
- be postmenopausal
- not have heart disease
- not be diabetic
- be willing to take estradiol
- want to control coronary heart disease
- be interested in good health
What Are the Benefits?Participation is for approximately 2.5 years after the screening period. During this time, the participant must come to the Atherosclerosis Research Unit on the USC Health Sciences Campus every 1 to 2 months for clinical and dietary evaluation, and noninvasive imaging of the arteries of the neck for atherosclerosis.
Participants must faithfully take the estradiol or placebo and avoid using other hormones during the trial. Each participant is also expected to keep food records and flushing diaries
FREE health monitoring and other benefits are available to qualified participants; including:Background of Atherosclerosis Prevention Research and ExperienceUltrasound scanning of the arteries in the neck - a noninvasive method for assessing atherosclerosis Cholesterol measurements Monitoring of blood pressure Dietary assessment Mammograms Pelvic examinations Cognitive testing Annual EKG Supervision of your clinical progress by a team of physicians, nurses, and dietitians
The Atherosclerosis Research Unit at the University of Southern California (USC) has been a recognized leading center for atherosclerosis research and its prevention for over 25 years. For the past 10 years, this center has conducted several large studies with focus on women’s health and the prevention of atherosclerosis. Along with scientists at the Jet Propulsion Laboratory, pioneering research at this center has resulted in development of arterial imaging tools commonly used in clinical investigation of atherosclerosis prevention. This center was the first to conclusively demonstrate that atherosclerosis in humans is reversible and that estradiol therapy slows atherosclerosis progression. The primary mission of the USC Atherosclerosis Research Unit is to help establish national public health policies and strategies for the prevention of cardiovascular disease (heart, stroke, and peripheral vascular disease), the number one killer of men and women. As we move into a new century of research and discovery, evaluation of reduction of atherosclerosis in healthy postmenopausal women with hormone therapy has become a major focus. Based upon well-founded research, we are at the crossroads of confirming whether estrogen therapy reduces atherosclerosis progression, one of the earliest indicators of heart disease, in postmenopausal women. ELITE, a federally funded National Institutes of Health (NIH) project, is a noninvasive arterial imaging trial designed to provide some of these answers within a relatively short period of time.
Researchers at Kaiser Permanente have been involved in a variety of important studies of the effects of estrogen on disease in women. Many of these studies have been collaborations with USC.
Working together, researchers at USC and Kaiser Permanente are now in a position to assess whether estradiol (the identical estrogen hormone that a woman's body makes) reduces atherosclerosis progression, one of the earliest indicators of heart disease, in postmenopausal women.
To Help You Decide and Further Determine Your Eligibility
* CALL the Atherosclerosis Research Unit (ARU) clinic for more information and a preliminary eligibility review by telephone
(866) 240-1489 (Toll free)
or (323)442-3658
8:00 AM - 3:00 PM
Monday through Friday
* Attend the screening visits at the USC ARU clinic where you will learn more about the program
* Discuss the program with your doctor
The screening visits do not obligate you in any way. They are to help you and the clinic staff decide if you would benefit from participating in the program.
Clinic: 2250 Alcazar Street
Suite 132
USC, Keck School of Medicine
Los Angeles, CA 90033
(866) 240-1489 (Toll free)
(323)442-3658
8:00 AM - 3:00 PM
Monday through Friday
aru@usc.edu