Precutaneous High Risk Patent Foramen Ovale to Treat Migraine Headaches

Summary

The foramen ovale, a kind of physiologic channel in the interatrial septum in the heart at embryonic stage, is closed normally at 5-7 months after birth. When it is not closed, it is referred to as the patent foramen ovale (PFO), which is found in approximately 1/4 of general population. It was shown in the studies in recent years that the risks of cryptogenic stroke, migraine, peripheral arterial embolism and decompression sickness in the patients with PFO were several times higher than those in healthy people. Therefore, PFO, previously considered a condition without the necessity of treatment, causes the attention of many experts and scholars around the world. Migraine with or without aura is defined as one of the most disabling chronic diseases, since according to WHO, the disability adjusted life year caused by migraine was second only to that by non-fatal stroke in 2005. In recent years, an increasing number of researches suggested that migraine is closely related to the right-to-left shunt (RLS) in the heart. And PFO is clinically considered as the most common cause of RLS.

The closure treatment for PFO-induced migraine has been gradually applied in several hospitals in China. The relationship of PFO with migraine, however, was not evaluated systematically based on specific standards, unfortunately leading to non-inclusion of many high-risk patients with PFO in the evaluation. The following aspects are to be fully recognized: the selecting and screening procedures for the high-risk population with PFO-induced migraine; the indications and standards of closure treatment for PFO in the patients with PFO-induced migraine; and the possibility that the made-in-China occluders substitute for those imported in the prevention from migraine. Furthermore, there is still a lack of prospective, multi-center, randomized and controlled studies in this subject, and standard or normal screening and treatment procedures have not yet been established in China. From this point, the investigators developed the Chinese people-specific procedures and standards of diagnosis of PFO-induced migraine in this study, based on current standards and methods of diagnosis, treatment and prevention of PFO-induced migraine in foreign countries. And the investigators prospectively adopted continuous inclusion of the high-risk patients with PFO-induced migraine, who were randomly divided into the closure treatment (transcatheter closure of PFO) group and the medication (drugs administered alone) group at the ratio of 1:1., in order to evaluate if the interventional treatment is better than the medication alone in these patients, to assess the efficacy and safety of the made-in-China occluders in the interventional treatment and prevention of PFO-induced migraine, and to identify the incidence of PFO in the patients with migraine in China and develop the Chinese people-specific screening protocols of PFO-induced migraine.

Conditions

• Patent Foramen Ovale

Interventions

PROCEDURE

the transcatheter closure of PFO

the transcatheter closure of PFO was performed using the made-in-China occluders approved by SFDA,clopidogrel(50mg/d, 3mon) , aspirin (0.1g/d, 6mon), i.e. oral administration of aspirin (0.1g/d) and clopidogrel (50mg/d) at 48h before the closure; the low molecular weight heparin (LMWH) was routinely given at 48h after the closure; and some pain-relief drugs could be temporarily administered in the patients with acute onset of migraine.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• Air Force Military Medical University, China

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  lead OTHER

Principal Investigators

• Zhang Yu Shun, PHD · First Affiliated Hospital of Xian JiaotongUniversity

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2018-01-31

Completion

2018-06-30

Countries

• China

Study Locations