Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chinese Academy of Medical Sciences, Fuwai Hospital
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants must meet all of the following criteria:
1. Aged 18 to 64 years at Visit 1.
2. Diagnosis of migraine with or without aura confirmed by a neurologist, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
3. History of migraine for more than 1 year, with an average of at least 4 migraine days per month during the 12-week screening period, as recorded in a headache diary and confirmed by the investigator at Visit 2.
4. Patent foramen ovale (PFO) diagnosed by transcranial Doppler (TCD), transthoracic echocardiography (TTE), or transesophageal echocardiography (TEE), with a right-to-left shunt at the atrial level.
5. Provision of written informed consent and willingness to comply with follow-up procedures.
You may not be if
Participants will be excluded if any of the following apply:
1. Secondary headache attributable to other causes.
2. History of transient ischemic attack, stroke, or intracranial hemorrhage.
3. History of pacemaker implantation, atrial septal defect closure, or left atrial appendage closure.
4. Right-to-left intracardiac shunt due to causes other than PFO.
5. Contraindications to antiplatelet or anticoagulant therapy, including thrombocytopenia, major trauma, active bleeding, decompensated cirrhosis, or drug allergy.
6. Contraindications to beta-blocker therapy, including hypotension, severe bradycardia, atrioventricular block, asthma, or drug allergy.
7. Poorly controlled atrial fibrillation at Visit 1.
8. Poorly controlled hypertension at Visit 1, defined as blood pressure \>160/90 mmHg despite regular medication.
9. Inability to maintain a headache diary or to reliably report headache symptoms.
10. Use of anticoagulants (e.g., warfarin, rivaroxaban) or antiplatelet agents (e.g., aspirin, clopidogrel, ticagrelor) within 12 weeks prior to Visit 2.
11. Use of metoprolol within 12 weeks prior to Visit 2.
12. Pregnancy, intention to become pregnant during the study period, or planned elective surgery during the study period.
13. Any condition that, in the investigator's opinion, may pose significant risk, confound study results, or interfere with participation.
14. Any other reasons (e.g., likely non-adherence, inability to attend follow-up visits, or planned relocation) that render the participant unsuitable for the study in the investigator's judgment.
