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Percutaneous closure of patent foramen ovale in patients with migraine: a prospective non-randomized controlled study

A prospective study for closure therapy for prevention and treatment of migraine patient with patent foramen ovale

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032059
Enrollment
Unknown
Registered
2020-04-19
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

migraine

Interventions

Sponsors

Department of cardiology, Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Complying with the criteria of the International Classification of Migraine Disorders (with aura or without aura), 3rd edition; 2) The age of the first migraine attack was <= 50 years old; 3) A history of migraine for at least 12 months; 4) At least 6 attacks,during the 3 months pre-introduction period; 5) 2-4 attacks during 2 weeks introduction period; 6) Less than 7 Migraine days during 2 weeks preintroduction period; 7) Aged 16 to 65 year; 8) Subjects were able to accurately identify migraine and understand the investigator's instructions and were able to independently complete the headache-diary record; 9) Participants signed consent forms for this trial.

Exclusion criteria

Exclusion criteria: 1. Hemorrhagic stroke; 2. Pulmonary hypertension; 3. Right ventricular cardiomyopathy; 4. Pulmonary valve stenosis, pulmonary artery stenosis or right ventricular outflow tract stenosis; 5. Moderate to severe tricuspid regurgitation caused by various causes; 6. The headache can't match the criteria of paroxysmal migraine; 7. Combined with other types of headache, including consequential headache patients; 8. Patients with thrombocytopenia, glaucoma, peripheral vascular disease, or Raynaud's syndrome; 9. Participate in this trial and participate in other clinical trials within the first 3 months of participation, including participation in drug therapy and alternative therapies (eg acupuncture, massage, percutaneous electrical stimulation, etc.); 10. Patients undergoing facial surgery of the sphenopalatine ganglion region due to plastic surgery, correction, treatment, or trauma; 11. Combined with liver and kidney function damage: ALT >= 3 x ULN; AST >= 3 x ULN 3; Cr >= ULN; TBIL>= 2 x ULN; 12. Patients with other serious cardiovascular and hematopoietic diseases and hematopoietic diseases; patients with malignant tumors; 13. Patients who have recently undergone major surgery or trauma are not eligible to participate in this study; 14. Patients with schizophrenia, major depression (HAMD scale >24), alcohol dependence, history of drug abuse; 15. Pregnancy and breastfeeding women and those who have a birth plan within 3 months of the trial or after the stop of medication; 16. Allergies or encounter a wide range of drug allergies, or to study the ingredients of the medication for allergic persons; 17. Take painkillers >10 days/month; 18. Other patients who should not be involved in this study.

Design outcomes

Primary

MeasureTime frame
Cessation of headache;The frequency of headache attacks per month decreased by 50%;he number of headache days attacks per month decreased by 50%;

Secondary

MeasureTime frame
Headache Impact Test-6;reduction in migraine headache attacks;reduction in migraine headache days;

Countries

China

Contacts

Public ContactXuyan Ding

Department of Cardiology, Zhejiang Provincial People's Hospital

lee3163003@163.com+86 13989838256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026