Approximately 10-15% of all Europeans suffer from migraines. Recent research suggests, among other things, a link between migraines and a common heart defect, a patent foramen ovale (PFO, "oval hole"). A PFO is a small opening between the upper chambers of the heart, which occurs in about 25% of the population. Blood flowing through this opening bypasses the filtration system of the lungs.
Studies have shown that people who suffer from severe migraines are more likely to have a patent foramen ovale (PFO). Therefore, it is suspected that migraine attacks are triggered by small blood clots that reach the brain along with unfiltered blood passing through the PFO. In certain cases, these blood clots can disrupt brain metabolism and cause migraine attacks.
The PRIMA study on patent foramen ovale and migraine
The current study on migraine is examining patients in whom this possible connection between their headaches and the PFO is to be clarified.
The Kiel Pain Clinic is one of the international testing centers where neurologists and cardiologists are investigating this connection.
What is the PRIMA study?
This clinical study helps determine whether a common heart defect, patent foramen ovale (PFO), contributes to migraine attacks.
The PRIMA study is a randomized trial. This means that participants have a 50:50 chance of receiving PFO closure and the corresponding treatment, or of receiving treatment according to the current standard without PFO closure.
The minimally invasive procedure takes about an hour and is performed by specialized cardiologists.
How is the PRIMA study conducted?
Participants are randomly assigned to one of two groups. One group receives the PFO closure and is treated according to current standards. The second group does not receive the closure but is treated according to current standards.
Study participants will receive free care as part of the study. Specialized physicians will monitor both patient groups throughout the study period. The results will be recorded and compared for both groups. The study has been reported to the relevant authorities.
Who can participate?
To participate in the PRIMA study, the following criteria must be met:
- Ages between 18 and 65, whereby the onset of migraine attacks must have occurred before the age of 50
- Diagnosis of migraine with aura
- Unsuccessful treatment with at least two generally accepted preventive medications
Even if you meet the above criteria, your further medical history and other factors will be taken into account to determine whether you are eligible for the study.
Participation in the study is free of charge.
How do I get included in the PRIMA study?
If you would like more information about the PRIMA study, please contact our registration office:
- Tel.: 0431-20099400.
A series of questions will be answered to determine if you meet the basic criteria. If so, an appointment for a personal examination will be scheduled. Before participating in the study, participants will receive an informed consent form, which they must read and which contains further information about the therapy within the study and what to expect. The study design will be explained in detail, and participants will have the opportunity to ask questions.
The initial tests for inclusion in the study include:
- the recording of the medical history,
- a headache diary kept over 3 months,
- completing the questionnaire on quality of life,
- the Beck Depression Inventory (BDI),
- completing the questionnaire to assess your functional impairment due to migraine (MIDAS questionnaire),
- clinical neurological examinations,
- Routine blood tests, ECG and TCD (transcranial Doppler ultrasound) or TTE (transthoracic echo) for right-to-left shunt.
What happens after I am enrolled in the study?
Patients are asked to keep a headache diary and receive neurological monitoring for one year. Patients undergoing PFO closure are also monitored by a cardiologist during this time and examined annually thereafter.
You can find more information in the information flyer .
Source: http://primatrial.com/
Hello, I'm male and 58 years old. Since I was 15, so for several decades now, I've had regular migraines with aura (flashes of light, visual disturbances, and headaches). I get them about 6-7 times a year, without a break, all these years. Two years ago, I suffered a stroke. During this time, an oval foramen was discovered, which I knew absolutely nothing about! I had it closed at the Aschaffenburg Clinic, and I haven't had an attack in two years. Of course, I hope it stays that way. I know that the research on this is unclear. Personally, I suspect there might be a connection. Since I was searching intensively for reports from others at the time, I decided to share my own experience.
I had a PFO occluder inserted in 2021 due to two strokes. Before, I had a migraine attack with an aura almost every month. Since the umbrella was inserted, I haven't had a single migraine attack.
Hello,
My name is Carolin, I'm 34 and I've had migraines with aura for about 15 years. I used to have a severe headache/nausea after a visual aura on the left (flashes of light) and now it's mainly just the aura without a headache.
For some time now he has also had speech and emotional disorders. @Gaby: I was diagnosed with an open foramen ovale 10 years ago due to another illness that required surgery.
Were you referred by a neurologist for OFP closure? I've read about the connection before and am thinking about pursuing it further. The auras are sometimes very stressful and sometimes every 4 weeks.
Hello, my name is Roger Widmer,
I have had migraine attacks with aura since I was a child. When I was just over 50 years old, these attacks became so severe that
I could hardly do regular work anymore. I reported to a clinic in Zurich,
where I underwent a test program was able to take part with some new medications, the medication Relpax helped me best with a migraine attack, but there was one problem, with 12 to 15 attacks a month, you can easily become dependent on these medications.
As “chance” would have it, I got a thrombosis in my left leg out of the blue, and I was examined more closely and, in addition to a blood disorder, they also found a PFO and it was shown that I had already had a few very small embolisms must have. On June 30, 2010, an umbrella was inserted into me at the Inselspital in Bern.
Since that day things have been improving for me and I think it's getting better and better, if I ever have a headache a normal headache tablet is enough or nothing!
Many greetings, Roger Widmer
Hello,
my name is Melina and I'm 38 years old. I had migraines even as a small child. The older I got and my pregnancy, my attacks became more and more severe... First, eye flickering, then sensitivity to light, nausea and depending on which side of the brain they are The attack was accompanied by symptoms of paralysis... I had tried every medication and nothing helped... The attacks became more and more frequent due to stress at work. One day I was sitting at work and noticed I was getting a headache. I took a tablet and the strange thing was, after 3 They were gone for a few minutes... I thought it was strange... I went to break, drank coffee and then it happened: I heard my colleague talking but it passed me by like I was watching a movie. I got a headache that I thought my eye was pushing it out. Then I started feeling sick. My boss came along and immediately noticed something was wrong... I was immediately taken to the hospital and had to do a few tests… The doctor then came and I asked, can I go home?? He no, Ms. Kaiser, they come immediately to the intensive stroke ward. That's when it happened. I had a stroke at the age of 34:-( after a few tests with an examination of the heart then said to me: Ms. Kaiser, you have a PFO and I what? A hole: that's why a blood clot went through and triggered the stroke... After 3 months it was closed and since then I've been totally fine... Not a day with a migraine attack :-) and that's been the case for 4 years... That's my story really happened...
Hello,
I had an anchor umbrella implanted (Frankfurt: St. Katharinen Hospital) in October 2010 and since then I have never had a migraine with an aura again. Before that I had an aura about 3-6 times a year. with vision and speech disorders. Unfortunately, the “normal” migraine did not change after the procedure. I had the hope that this would also work out. changed or disappeared completely. But the aura is completely gone - that's something :-) If you're interested, you can contact me! All I know is that most migraine patients. with aura have never heard of it and find it unbelievable :-( Even doctors don't provide information about it, you have to find out everything yourself. Kind regards, Gaby Zettl