Migraine with Patent Foramen Ovale
Conditions
Interventions
Medical Therapy Group:Administer/Take metoprolol tartrate tablets 25 mg by mouth twice daily to prevent migraines
PFO group:The patient will undergo PFO closure, followed by a 6-month course of oral aspirin (100 mg once daily) and clopidogrel (75 mg once daily)
Sponsors
The Seventh Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years. 2.Diagnosed with migraine with aura according to the ICHD-3 criteria, with a history of more than 1 year; 3.Migraine attack frequency of more than 1 day per week, with severe symptoms that significantly impact daily life; 4.Diagnosis of right-to-left shunt (RLS) at the atrial level (grade = III) confirmed by Transcranial Doppler (TCD) with bubble study and Transthoracic Echocardiography (TTE) with contrast (right heart contrast echocardiography). 5.No plans for other elective surgeries during the study period; 6.Provision of signed informed consent, and agreement to maintain a migraine diary during the study and participate in follow-up assessments after the study concludes; 7.Not pregnant and no intention to become pregnant during the study period.
Exclusion criteria
Exclusion criteria: 1.Secondary migraine caused by other etiologies. 2.Platelet count 3 mg/dL; 4.History of intracerebral hemorrhage, stroke, or transient ischemic attack (TIA). 5.Clear contraindications to antiplatelet medications and/or beta-blockers; 6.Clear contraindications to cardiac interventional procedures. 7.Post-operative status of pacemaker implantation, atrial septal defect closure, or left atrial appendage closure. 8.Intracardiac right-to-left shunt due to other causes. 9.Allergy/Hypersensitivity to any drug used in the study protocol. 10.Poorly controlled atrial fibrillation within 3 months prior to group assignment. 11.Poorly controlled hypertension. 12.Inability to maintain a headache diary or to independently describe/record headache status. 13.Arrhythmias such as atrioventricular block, sinus bradycardia, etc. 14.Acute phase of stroke; 15.Intracardiac thrombus formation, or complete occlusion caused by thrombosis of the inferior vena cava or pelvic veins. 16.Concurrent pulmonary hypertension, or PFO with a specific tunnel morphology. 17.Concurrent hemorrhagic disorders or bleeding tendency; concurrent systemic or local infection. 18.Presence of systemic or local infection;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events;Migraine-free rate;Average reduction in migraine attacks from baseline;Quality of Life score;Average reduction in migraine days from baseline;Rate of reduction in mean migraine days from baselin; | — |
Countries
China
Contacts
Public ContactHang yongbin
The Seventh Affiliated Hospital Sun Yat-sen University
Outcome results
None listed