Precutaneous High Risk Patent Foramen Ovale to Treat Migraine Headaches

• ClinicalTrials.gov Identifier: NCT02777359
• Recruitment Status: Unknown
• First Posted: May 19, 2016
• Last Update Posted: July 19, 2017
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Second Affiliated Hospital of Xi'an Jiaotong University; Air Force Military Medical University, China; Southwest Hospital, China
• Information provided by (Responsible Party): First Affiliated Hospital Xi'an Jiaotong University

Tracking Information

• First Submitted Date: May 4, 2016
• First Posted Date: May 19, 2016
• Last Update Posted Date: July 19, 2017
• Actual Study Start Date: January 2017
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 17, 2016): migraine days after randomization [ Time Frame: up to 1 year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Precutaneous High Risk Patent Foramen Ovale to Treat Migraine Headaches
• Official Title: Precutaneous High Risk Patent Foramen Ovale to Treat Migraine Headaches:A Prospective,Multicenter,Randomized,Controlled Trial

Brief 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Patent Foramen Ovale

Intervention

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.

Study Arms

• Experimental: the closure group
  In the closure group, the transcatheter closure of PFO was performed using the made-in-China occluders approved by SFDA, in combination of clopidogrel(50mg/d, 3mon) and 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.
  Intervention: Procedure: the transcatheter closure of PFO
• No Intervention: the medication group
  In the medication group, in combination of clopidogrel (50mg/d, 3mon) and aspirin (0.1g/d, 6mon), current medication resumed, including conventional prescription for migraine as β-receptor blockers, calcium-ion antagonists, antiepileptics, antidepressants and non-steroid anti-inflammatory drugs (NSAID).

• Publications *: Zhao E, Du Y, Xie H, Zhang Y. Modified Method of Contrast Transthoracic Echocardiography for the Diagnosis of Patent Foramen Ovale. Biomed Res Int. 2019 May 9;2019:9828539. doi: 10.1155/2019/9828539. eCollection 2019.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 17, 2016): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2018
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• migraine headaches with or without aura,migraine onset before age 50
• >3 migraine attacks or 5 migraine days per month
• failed ≥2 commonly accepted migraine medications:β-receptor blockers, calcium-ion antagonists, antidepressants and non-steroid anti-inflammatory drugs (NSAID).
• PFO documented by TTE or TEE
• PFO meet one of the following conditions:RLS in rest documented by cTTE or cTCD,combine with ASA,the primary patition mobility≥6.5mm,the diameter of PFO≥4mm, combine with Eustachian Valve or Chiari net.
• age 18-60
• else:independent in daily activities,to comply with complete follow-up experiment design

Exclusion Criteria:

• contraindication to antiplatelet or anticoagulant
• inferior vena cava or pelvic vein thrombogenesis leading to complete obstruction,systemic or local infection,septicemia,heart lumen thrombosis
• pregnancy
• combine with pulmonary hypertension or PFO made for a particular channel
• severe allergy to nickel

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02777359
• Other Study ID Numbers: XJTU1AF-CRF-2015-008
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
• Study Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University
• Air Force Military Medical University, China
• Southwest Hospital, China

Investigators

• Study Chair: Zhang Yu Shun, PHD; First Affiliated Hospital of Xian JiaotongUniversity

• PRS Account: First Affiliated Hospital Xi'an Jiaotong University
• Verification Date: July 2017