Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale

NCT06953622 | Recruiting

• 1 other identifier: M2024296
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

To establish a headache center in China that combines clinical, imaging and laboratory examinations, explore the feasible treatment options for migraine combined with patent foramen ovale, and search for the possible influencing factors, construct models that influence prognosis.

Conditions

Migraine; Patent Foramen Ovale

Outcome Measures

Primary Outcomes (1)

• The changes of migraine attacks

  Migraine attacks are an important indicator of improvement in symptoms. The comparison measures included headache frequency, duration, pain degree, VAS scores, HIT-6 scores, HAMA, HAMD, and PSQI.

  3 months, 6 months, 1 year, 2 years and 3 years

Study Arms (3)

Conservative group

Don't use antiplatelet drugs or undergo patent foramen ovale closure.

Drug: Conservative treatment

Antiplatelet group

The application of antiplatelet drug.

Drug: Antipaletet drug

PFO group

Receive a patent foramen ovale closure surgery.

Procedure: Patent Foramen Ovale Closure

Interventions

Conservative treatment DRUG

Receive no antipaletet drug treatment and surgery

Conservative group

Antipaletet drug DRUG

Use of antipaletet drugs.

Antiplatelet group

Patent Foramen Ovale Closure PROCEDURE

Receive the surgery of Patent Foramen Ovale

PFO group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All clinically confirmed migraine patients with PFO who met the inclusion criteria were included.

You may qualify if:

• Meet the diagnostic criteria for migraine in the International Classification of Headache (ICHD-3);
• Confirmation of patent foramen ovale through transthoracic echocardiography(TTE) or transesophageal echocardiography(TEE)/right heart contrast echocardiography
• Agree to participate in the study and sign the informed consent form.

You may not qualify if:

• Can not sign the informed consent form or cooperate with follow-up.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Foramen Ovale, Patent

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yu Fu

CONTACT

13671185050; lilac_fu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: May 1, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2025

Record last verified: 2024-07

Locations

CN (1)