Inova Fairfax Hospital Takes Part in National Migraine Study

Study to Determine if Closing a Small Hole in the Heart Can Stop Migraines

Falls Church, VA – (September 12, 2007) — Inova Fairfax Hospital is one of 35 hospitals nationwide taking part in the PREMIUM Migraine Clinical Trial. The purpose of the trial is to explore the link between migraine headaches and a common congenital heart defect called a patent foramen ovale (PFO), a tiny hole in the heart. Researchers want to determine if closing the PFO reduces the frequency or intensity of migraine headaches.

The possible connection between the PFO and migraine headaches was brought to the attention of physicians after some stroke patients who had their PFO closed to prevent future attacks discovered a welcome side effect – their migraine headaches either stopped completely or were less frequent and intense.

“Doctors treating these stroke patients were very surprised when some of the patients came back after their procedure saying their migraines had disappeared,” said James Thompson, MD, division chief, Pediatric Cardiology, Inova Fairfax Hospital for Children. “This study is specifically designed to look at migraine sufferers to see if closing the PFO can be an effective form of treatment.”

A PFO is a structural defect of the heart, found in about 20 percent of adults, that occurs when a small opening in the wall between the two upper chambers of the heart fails to close during infancy. When it remains open, blood can bypass the filtering system of the lungs and very small blood clots or chemicals can travel directly to the brain, possibly triggering migraine attacks.

To close the PFO, cardiologists implant a device made of two wire mesh discs that clasp the hole on either side, firmly closing the opening. The device is implanted by a catheter that is inserted in the patient’s groin. This minimally invasive procedure typically takes one hour and the patient is able to return home the same day.

Nationwide, the trial is expected to enroll about 450 people. The participants will be randomized, so half will receive the implant to close the PFO and half will undergo a simulated procedure. Neither the patient nor the physician following the participants will know which patients received the implant and which did not. All patients will keep a headache diary and physicians will follow the patients for 12 months after the procedure.

According to the National Headache Foundation, about 28 million Americans suffer from migraines. These headaches are typically characterized by pulsating pain, nausea and vomiting. Migraines are more common than asthma, diabetes and coronary heart disease combined.

Inova Health System is a not-for-profit health care system based in Northern Virginia that consists of hospitals and other health services including emergency and urgent care centers, home care, nursing homes, mental health and blood donor services, and wellness classes. Governed by a voluntary board of community members, Inova’s mission is to improve the health of the diverse community we serve through excellence in patient care, education and research.