UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051954 |
|---|---|
| Receipt number | R000058907 |
| Scientific Title | Impact of party ballooN inFlation maneuver during in saLine contrAst Transthoracic Echocardiography for detect Patent Foramen Ovale |
| Date of disclosure of the study information | 2023/08/21 |
| Last modified on | 2023/08/20 12:02:28 |
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Basic information
Public title
Diagnosis of patent foramen ovale in saline contrast transthoracic echocardiography using the party balloon inflation maneuver: A multi-center registry
Acronym
Diagnosis of patent foramen ovale using the party balloon: A multi-center registry
Scientific Title
Impact of party ballooN inFlation maneuver during in saLine contrAst Transthoracic Echocardiography for detect Patent Foramen Ovale
Scientific Title:Acronym
INFLATE-PFO study
Region
| Japan |
Condition
Condition
Patent Foramen Ovale
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This multicenter study aims to statistically elucidate whether the party balloon inflation maneuver, as compared to the conventional Valsalva maneuver, offers superior detection of patent foramen ovale during saline contrast transthoracic echocardiography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of microbubble grading in saline contrast transthoracic echocardiography between conventional valsalva maneuver and party balloon inflation maneuver
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases undergoing conventional valsalva maneuver stress and party balloon inflation maneuver during saline contrast transthoracic echocardiography to detect patent foramen ovale were consecutively enrolled from June 1, 2021 to March 31, 2024.
Key exclusion criteria
Cases with insufficiently recorded information necessary for analysis and those deemed inappropriate by the responsible physician for the study are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akihisa |
| Middle name | |
| Last name | Kataoka |
Organization
Teikyo University
Division name
Department of Internal Medicine, Division of Cardiology
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
kataoaki@sd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Akihisa |
| Middle name | |
| Last name | Kataoka |
Organization
Teikyo University
Division name
Department of Internal Medicine, Division of Cardiology
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
Homepage URL
kataoaki@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Akihisa Kataoka
Funding Source
Organization
Abbott Medical Japan LLC
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Medical Research Ethics Committee
Address
Address: 2-11-1 Kaga, Itabashi-ku, Tokyo
Tel
03-3964-7256
turb-office@teikyo-u.ac.jp
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
帝京大学医学部附属病院（東京都）
聖マリアンナ医科大学（神奈川県）
国立循環器病研究センター病院（大阪府）
国保旭中央病院（千葉県）
手稲渓仁会病院（北海道）
近森病院（高知県）
昭和大学病院（東京都）
群馬県立心臓血管センター（群馬県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 08 | Month | 20 | Day |
Last modified on
| 2023 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058907
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