UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017216 |
|---|---|
| Receipt number | R000019968 |
| Scientific Title | Transcatheter closure of patent foramen ovale in patients with migraine |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2018/12/18 17:07:27 |
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Basic information
Public title
Transcatheter closure of patent foramen ovale in patients with migraine
Acronym
PFO closure in migraine patients
Scientific Title
Transcatheter closure of patent foramen ovale in patients with migraine
Scientific Title:Acronym
PFO closure in migraine patients
Region
| Japan |
Condition
Condition
Migraine
Classification by specialty
| Medicine in general | Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluat of efficacy and safety of transcatheter closure of patent foramen ovale in patients with migraine headach
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Whether subjects with percutaneous PFO closure experience of migraine attacks.
Key secondary outcomes
Days, Degree, comorbidity related with migraine
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Amplatzer PFO Occluder
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with migraine headache and patent foramen ovale (PFO)
Key exclusion criteria
Patients without PFO
Patients having contraindicated anticoagulation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TEIJI AKAGI |
Organization
Okayama University Hospital
Division name
Cardiac Intensive Care Unit
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7357
t-akagi@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TEIJI AKAGI |
Organization
Okayama University Hospital
Division name
Cardiac Intensive Care Unit
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7357
Homepage URL
t-akagi@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 18 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 18 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 21 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019968
