Women’s Cardiac Trial Uses Ultrasound to Check Health of Vessels
July 05, 2007
Specialists with the Strong Women’s Heart Program are expanding a study that considers the effects of a statin drug on metabolic syndrome, a condition that increases women’s risk for heart disease and stroke. Volunteers enrolled in the second phase of the trial additionally undergo a noninvasive ultrasound test to determine the thickness of the inner lining of the carotid arteries, in an effort to predict the risk of potential cardiac events.
Metabolic syndrome is a collection of health risk factors that include being overweight, having borderline glucose (sugar) levels, borderline blood pressure, and abnormal cholesterol levels with high triglycerides (fat content in blood). People with three or more risk factors are considered to have metabolic syndrome.
The purpose of both phases of the study is to evaluate the effect of an atorvastatin, in this case, Lipitor, on important blood markers known to be abnormal in the syndrome, Velarde said. The hope is to determine the ability of statins to lower risk factors of the condition, and to determine the impact of treatment on the syndrome’s individual components. Atorvastatin is approved by the U.S. Food and Drug Administration for the treatment of high cholesterol.
This second phase of the study expands the number of women involved, incorporates a control group of women who do not have metabolic syndrome, and utilizes ultrasound imaging to check the carotid arteries, according to cardiologist Gladys Velarde, M.D., director of the Strong Women’s Heart Program at the University of Rochester Medical Center.
“The more we know about metabolic syndrome and how statins impact a woman’s health, the closer we will be to decreasing the risk of heart disease and stroke in women who have the syndrome,” Velarde said.
Volunteers should be between the ages of 18 and 75, not pregnant and not planning to become pregnant in the next 12 months. Members accepted into the small control group will not have metabolic syndrome, while another, larger group of volunteers must have at least three of the five components that comprise metabolic syndrome.
Nearly 100 women will be enrolled, most with metabolic syndrome but a portion who are normal, whose data will be used to compare ultrasound results. Participation will last 18 weeks and involve four or five brief visits to the Strong Women’s Heart Program office. Follow-up is done on a regular basis by telephone. Members of the control group will have only one visit which involves lab work and ultrasound imaging.
Volunteers that meet the criteria for the metabolic syndrome are assigned to one of two study groups. Starting the first week, members of both groups are on the American Heart Association Step 1 diet, a low-fat program designed to reduce the risk of cardiovascular disease. All continue their diet plans through the end of the study.
Starting the sixth week, members of one group receive a statin drug, the other a placebo, to be taken through the end of the study. Neither volunteers nor researchers know which group volunteers are in.