Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking University Third Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Can not sign the informed consent form or cooperate with follow-up.
Trial population
All clinically confirmed migraine patients with PFO who met the inclusion criteria were included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Conservative treatment
DrugReceive no antipaletet drug treatment and surgery
Antipaletet drug
DrugUse of antipaletet drugs.
Patent Foramen Ovale Closure
Procedure/SurgeryReceive the surgery of Patent Foramen Ovale
Treatment groups
330 Participants
are divided into 3 treatment groupsGroup A: Conservative group1 intervention
Group B: Antiplatelet group1 intervention
Group C: PFO group1 intervention
Trial outcomes
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.
Time frame
3 months, 6 months, 1 year, 2 years and 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov