More clinical trials are beginning to continue investigating the link between patent foramen ovale (PFO) and Migraine. A PFO is a hole in the wall that divides the right and left chambers of the heart. We all have a PFO during before birth, but it usually closes before birth.
Research has shown a higher prevalence of PFO among Migraineurs. Small observational and case-control studies indicate that patients with stroke of unknown origin have a higher incidence of patent foramen ovale. It's still under investigation whether PFO closure prevents recurrent strokes. It is also thought possible that blood without enough oxygen may trigger a Migraine when it reaches the brain. (For a more comprehensive explanation of PFO and Migraine, please see PFO: A hole in the heart affecting Migraine?)
In addition to the MIST trial that was conducted in the U.K. and the MIST II trial now underway in the U.S., another clinical trial is now open for enrollment. The ESCAPE trial is a controlled, randomized, blinded study to determine if PFO closures will actually reduce the frequency of Migraine attacks enough to be a therapy option for patients with Migraine disease. The study will be conducted at 45 leading headache clinics and 15 leading interventional cardiology clinics throughout the United States.
St. Jude Medical’s Premere™ PFO Closure System, which will be used in the ESCAPE study (Effect of Septal Closure of Atrial PFO on Events of Migraine), was specifically designed for PFO closures and was one of the products acquired by the Company through the 2005 acquisition of Velocimed. During the implant procedure, physicians deliver the device through the PFO and then open the device’s two sides independently, allowing physicians precise placement to effectively close the PFO. Implanted through a transcatheter approach as is being used in the MIST trials, this procedure is far less invasive than open-heart surgeries previously used to close PFOs. This study will compare PFO closure with medical therapy alone for Migraine treatment.
More about the study:
Inclusion Criteria:
- Patient must be between the ages of 18 and 55;
- Patient must have a migraine history and demonstrate a refractoriness to medical treatment;
- Patient must have a Patent Foramen Ovale - PFO;
- Patient must be willing and able to give informed consent and complete required follow-up visits.
Exclusion Criteria:
- Patient has any medical condition or receives any medication that would preclude participation in the trial
- Patient is enrolled or intends to participate in another clinical study (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrollment in the study.
- Patient is pregnant, or intends to become pregnant during the trial period
Some trial centers are currently recruiting. Others will be recruiting study participants soon. You can monitor and get contact information at ClinicalTrials.gov.
_____________
Sources:
- Press release. "St. Jude Medical Announces First Implant in Its Migraine Headache Study." St. Jude Medical. St. Paul. April 18, 2006.
- U.S. National Institutes of Health. ClinicalTrials.gov.
ESCAPE
Migraine Trial.
