Foramen Ovale, PatentEASTFORMNCT02127294
Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
A study testing transcatheter patent foreman ovale closure in people with Foramen Ovale, Patent and Migraine, run by Yi Yang at 1 site in China.
Trial summary
The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Foramen Ovale, Patent, Migraine
- What is being tested?
- transcatheter patent foreman ovale closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders
- Transcranial Doppler evidence of right-to-left shunt(RLS) and echocardiographic evidence of PFO，of which the degree is moderate to large RLS
- Subjects who have not responded to or cannot take common migraine preventive medications
- Willing to participate in follow-up visits
- Additional Inclusion Criteria:
- Transcatheter closure group: Closure of PFO is performed
- Contrast group: Subjects who meet the Inclusion Criteria, but refuse to undergo closure procedure
Who cannot join
- Seizure disorder
- Other organic central nervous system disease
- Subjects whose headaches are other than migraine, such as a result of traumatic head or neck injury
- Evidence of alcohol, drug or substance abuse within the previous year
- Additional Exclusion Criteria for Transcatheter closure group:
- Subjects with intracardiac thrombus or tumor
Show all 12Show fewer
- Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
- Subjects with left ventricular aneurysm or akinesis
- Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
- Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
- Subjects with contraindication to aspirin or Clopidogrel therapy
- Pregnant or desire to become pregnant within the next year
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.
- Conditions
- Foramen Ovale, Patent, Migraine
- Being tested
- transcatheter patent foreman ovale closure
- Keywords
- Foramen Ovale, Patent, migraine, transcatheter patent foramen ovale closure, contrast-enhanced transcranial Doppler, Transthoracic Echocardiography
- Medical subject headings
- Foramen Ovale, Patent, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter patent foreman ovale closureDevice
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter closure group | Experimental | Migraine patients with patent foreman ovale (PFO)，who meet the criteria and agree to conduct closure of patent foramen ovale will be selected to this group. Receives: Device: transcatheter patent foreman ovale closure |
| Contrast group | No intervention | Migraine patients with PFO，who meet the criteria but don't agree to conduct closure of patent foramen ovale will be selected to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-enhanced Transcranial Doppler
Patients in transcatheter closure group are required to perform contrast-enhanced Transcranial Doppler at 1 month, 3 month, 6 month and 1 year after closure, respectively.
Measured: within one year period
Secondary outcomes (1)
Headache Impact Test-6
All patients complete HIT-6 score at baseline. Patients in transcatheter closure group follow-up at 1 month, 3 month, 6 month and 1 year after closure, respectively. Patients in contrast group follow-up twice during one year period.
Measured: within one year period, at least 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Foramen Ovale, PatentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
- Investigators
- Yi Yang, MD, PhD, Study chair, The First Hospital of Jilin UniversityYingqi Xing, MD, PhD, Study director, The First Hospital of Jilin UniversityYuzhu Guo, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127294
- Sponsor's protocol ID
- PFO-1shsf
- Acronym
- EASTFORM
- Status last verified
- Jan 2016
- First submitted
- 29 Apr 2014
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang Y, Guo ZN, Wu J, Jin H, Wang X, Xu J, Feng J, Xing Y. Prevalence and extent of right-to-left shunt in migraine: a survey of 217 Chinese patients. Eur J Neurol. 2012 Oct;19(10):1367-72. doi: 10.1111/j.1468-1331.2012.03793.x. Epub 2012 Jun 30.
PubMed 22747847Xing YQ, Guo YZ, Gao YS, Guo ZN, Niu PP, Yang Y. Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM) Trial. Sci Rep. 2016 Dec 14;6:39081. doi: 10.1038/srep39081.
PubMed 27966652
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
- ClinicalTrials.gov ID
- NCT02127294
- Acronym / sponsor ID
- EASTFORM / PFO-1shsf
- Conditions
- Foramen Ovale, Patent, Migraine
- Keywords
- Foramen Ovale, Patent, migraine, transcatheter patent foramen ovale closure, contrast-enhanced transcranial Doppler, Transthoracic Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter closure group | Experimental | Device: transcatheter patent foreman ovale closureMigraine patients with patent foreman ovale (PFO)，who meet the criteria and agree to conduct closure of patent foramen ovale will be selected to this group. |
| Contrast group | No intervention | –Migraine patients with PFO，who meet the criteria but don't agree to conduct closure of patent foramen ovale will be selected to this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders
- Transcranial Doppler evidence of right-to-left shunt(RLS) and echocardiographic evidence of PFO，of which the degree is moderate to large RLS
- Subjects who have not responded to or cannot take common migraine preventive medications
- Willing to participate in follow-up visits
- Transcatheter closure group: Closure of PFO is performed
Key exclusion criteria (12 listed)
- Seizure disorder
- Other organic central nervous system disease
- Subjects whose headaches are other than migraine, such as a result of traumatic head or neck injury
- Evidence of alcohol, drug or substance abuse within the previous year
- Subjects with intracardiac thrombus or tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcatheter patent foreman ovale closure | Device | Transcatheter closure group |
Primary outcome
Contrast-enhanced Transcranial Doppler
Time frame: within one year period
Patients in transcatheter closure group are required to perform contrast-enhanced Transcranial Doppler at 1 month, 3 month, 6 month and 1 year after closure, respectively.
1 secondary outcome
Headache Impact Test-6
Time frame: within one year period, at least 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Background: PubMed 22747847Yang Y, Guo ZN, Wu J, Jin H, Wang X, Xu J, Feng J, Xing Y. Prevalence and extent of right-to-left shunt in migraine: a survey of 217 Chinese patients. Eur J Neurol. 2012 Oct;19(10):1367-72. doi: 10.1111/j.1468-1331.2012.03793.x. Epub 2012 Jun 30.
- Derived from this study: PubMed 27966652Xing YQ, Guo YZ, Gao YS, Guo ZN, Niu PP, Yang Y. Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM) Trial. Sci Rep. 2016 Dec 14;6:39081. doi: 10.1038/srep39081.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Yang, MD, PhD study chair
The First Hospital of Jilin University
Yingqi Xing, MD, PhD study director
The First Hospital of Jilin University
Yuzhu Guo principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcatheter patent foreman ovale closure in people with Foramen Ovale, Patent and Migraine, run by Yi Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-enhanced Transcranial Doppler (time frame: within one year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02127294, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.