Research Study Evaluates Stroke Prevention Treatment

December 16, 2004

WINSTON-SALEM, N.C. – Doctors at Wake Forest University Baptist Medical Center are evaluating a new treatment designed to prevent strokes caused by a small heart defect. The defect, patent foramen ovale (PFO), is believed to cause 50,000 strokes a year, especially in younger people.

“Strokes can be especially devastating in younger people because they can result in lifelong disability,” said Kerstin Bettermann, M.D., Ph.D., a neurologist at Wake Forest Baptist. “We need to know which treatment is the best way to prevent stroke.”

The study, being conducted at 80 centers nationwide, compares two treatments for PFO, which is a small flap-type opening between the right and left upper chambers of the heart. Doctors believe that the opening can lead to the formation of blood clots that can travel to the brain and cause stroke. About 15 percent to 25 percent of people have PFO, though many are not diagnosed until they have a stroke.

There are currently no guidelines on how to treat patients with PFO who have strokes. Patients are either placed on medicines such as aspirin or a blood-thinning medication called Coumadin®, or the hole is closed with an implant.

“The best medical treatment remains unknown until a research study is done,” said Bettermann. “This important study evaluates how to best prevent repeated strokes in patients with PFO. It will involve 1,600 participants and will last four years.”

The implant, called the STARFlex Septal Closure system, is made of a wire framework with a fabric covering. It is inserted through a vein the leg, similar to a heart catheterization procedure. The device is positioned in the heart using ultrasound and X-rays as a guide.

Wake Forest Baptist is still recruiting patients for the study. Participants must be between 18 and 60 years old, have had a mini-stroke or stroke caused by PFO, and not have other heart disease or blood clotting problems. For more information, call Theresa Johnson-Crews, R.N., study coordinator, at 336-716-2008.

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Media contacts: Karen Richardson,; or Shannon Koontz,; at 336-716-4587.

About Wake Forest University Baptist Medical Center: Wake Forest Baptist is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University School of Medicine. It is licensed to operate 1,282 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of “America’s Best Hospitals” by U.S. News & World Report.

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