UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054423 |
|---|---|
| Receipt number | R000062098 |
| Scientific Title | Optimization of Party Balloon Inflation Maneuver in Transthoracic Echocardiography |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/11/18 12:29:42 |
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Basic information
Public title
Optimization of Party Balloon Inflation Maneuver in Transthoracic Echocardiography
Acronym
Optimization of Party Balloon Inflation Maneuver
Scientific Title
Optimization of Party Balloon Inflation Maneuver in Transthoracic Echocardiography
Scientific Title:Acronym
Optimization of Party Balloon Inflation Maneuver
Region
| Japan |
Condition
Condition
patent foramen ovale, hypertrophic obstructive cardiomyopathy
Classification by specialty
| Medicine in general | Cardiology | Neurology |
| Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. What do we know so far and what do we not know?
We know that paradoxical embolism due to patent foramen ovale (PFO) is a potential cause of cerebral infarction. The conventional Valsalva maneuver has shown good sensitivity, specificity, and positive predictive value for diagnosing PFO on contrast transthoracic echocardiography . However, both patients and examiners often struggle to determine if sufficient loading has been achieved. Compared to the conventional Valsalva maneuver, a party balloon maneuver method developed by us has been shown to be more visible and effective for patients with insufficient loading . Additionally, the balloon maneuver has been successfully used to induce left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy who cannot perform the conventional maneuver . However, there is currently no standardized protocol for the party balloon maneuver, leading to variations in balloon size, inflation method, and contrast agent infusion timing among examiners and institutions.
2. What are we trying to clarify?
The purpose of this study is to develop an optimal protocol of conditions and methods for performing the party balloon maneuver most effectively.
3. What is to be gained from this?
It is hoped that the optimal protocol developed in this study will facilitate the widespread adoption of the party balloon maneuver as a diagnostic method for PFO and hypertrophic cardiomyopathy.
References:
1. Takaya T, et al. J Am Soc Echocardiogr 2020;33:201-6.
2. Kataoka A. et al. J Am Coll Cardiol Case Rep. 2022;4:102-4.
3. Kito K, Kataoka A, et al. EHJ Case Rep. 2023;7:ytad156.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic Measurement of Balloons
Using several commercially available balloons of various sizes, measure the lateral diameter of the inflated balloons using calipers. Additionally, measure the air pressure of each balloon with an air pressure gauge to determine the optimal balloon size and degree of inflation for the load.
Transthoracic Echocardiography
Healthy adult volunteers will be included in the study. Two experienced physicians (one male and one female) specializing in echocardiography will use transthoracic echocardiography in the left lateral position in the Physiology Laboratory of the Central Laboratory of our institution. The hemodynamic effects of the party balloon maneuver were investigated using the protocol obtained from Experiment 1. This was compared to rest and the Valsalva maneuver (VM) using transthoracic echocardiography. Right ventricular inflow-velocity time integral (RV inflow-VTI) and left ventricular end-diastolic diameter (LVDd) were measured during and after the maneuver to assess changes in venous return. The various measurements were analyzed offline with images acquired after the examination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Valsalva maneuver
Interventions/Control_2
Party balloon maneuver using smaller baloon inflated to a diameter of 5cm
Interventions/Control_3
Party balloon maneuver using smaller baloon inflated to a diameter of 15cm
Interventions/Control_4
Party balloon maneuver using larger baloon inflated to a diameter of 7cm
Interventions/Control_5
Party balloon maneuver using larger baloon inflated to a diameter of 15cm
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers who are employees of Teikyo University hospital and have obtained consent.
Key exclusion criteria
Cases with respiratory or cardiac disease. Cases in which sufficient information necessary for analysis could not be obtained, and other cases deemed inappropriate by the investigator.
Target sample size
50
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 City, 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
03-3964-1211
Address
2-11-1 Kaga, Itabashi City, Tokyo
TEL
03-3964-1211
Homepage URL
kataoaki@sd5.so-net.ne.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Medical Research Ethics Committee Bureau
Address
2 Chome-11-1 Kaga, Itabashi City, 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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
117
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
Main results already published
Date of protocol fixation
| 2023 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062098
