We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Precutaneous High Risk Patent Foramen Ovale to Treat Migraine Headaches

This study is currently recruiting participants.
Verified July 2017 by First Affiliated Hospital Xi'an Jiaotong University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02777359
First Posted: May 19, 2016
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Second Affiliated Hospital of Xi'an Jiaotong University
Fourth Military Medical University
Southwest Hospital, China
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University
  Purpose

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.


Condition Intervention Phase
Patent Foramen Ovale Procedure: the transcatheter closure of PFO Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Precutaneous High Risk Patent Foramen Ovale to Treat Migraine Headaches:A Prospective,Multicenter,Randomized,Controlled Trial

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital Xi'an Jiaotong University:

Primary Outcome Measures:
  • migraine days after randomization [ Time Frame: up to 1 year ]

Estimated Enrollment: 100
Actual Study Start Date: January 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777359


Contacts
Contact: Zhang Yu Shun, PHD 0086-029-85324625 zys2889@sina.com

Locations
China, Shaanxi
First Affiliated Hospital of Xian JiaotongUniversity Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Zhang Yu Shun, PHD    0086-029-85324625    zys2889@sina.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Second Affiliated Hospital of Xi'an Jiaotong University
Fourth Military Medical University
Southwest Hospital, China
Investigators
Study Chair: Zhang Yu Shun, PHD First Affiliated Hospital of Xian JiaotongUniversity
  More Information

Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02777359     History of Changes
Other Study ID Numbers: XJTU1AF-CRF-2015-008
First Submitted: May 4, 2016
First Posted: May 19, 2016
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
patent foramen ovale
migraine
treatment

Additional relevant MeSH terms:
Migraine Disorders
Headache
Foramen Ovale, Patent
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Aspirin
Heparin, Low-Molecular-Weight
Dalteparin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents