UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054098 |
|---|---|
| Receipt number | R000061783 |
| Scientific Title | Establishment of a method for isolating pulmonary artery waveform non-invasively |
| Date of disclosure of the study information | 2024/04/09 |
| Last modified on | 2024/04/09 20:29:08 |
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Basic information
Public title
Establishment of a method for isolating pulmonary artery waveform non-invasively
Acronym
Establishment of a method for isolating pulmonary artery waveform non-invasively
Scientific Title
Establishment of a method for isolating pulmonary artery waveform non-invasively
Scientific Title:Acronym
Establishment of a method for isolating pulmonary artery waveform non-invasively
Region
| Japan |
Condition
Condition
Patients suspected of having pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is a multi-center interventional research utilizing a combo wire catheter. It targets patients undergoing right heart catheterization due to suspected pulmonary hypertension. By inserting the combo wire into the pulmonary artery, pressure and flow velocity are measured simultaneously. These measurements are then calculated using the Wave Intensity and Water Hammer equation formulas to isolate and quantify the pulmonary artery waveform into forward and reflected waves. On the same day, prior to the catheterization, study collaborators perform an echocardiogram to estimate forward and reflected waves using a similar method based on the Doppler-derived right ventricular outflow tract waveform and tricuspid regurgitation waveform. The study aims to compare and correlate the pulmonary artery isolated wave pressure obtained via the combo wire catheter with that derived from the echocardiogram Doppler method.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of estimated pulmonary artery isolated wave pressure obtained using a combo wire catheter and echocardiogram Doppler method
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
This study is a multi-center interventional research utilizing a combo wire catheter. It targets patients undergoing right heart catheterization due to suspected pulmonary hypertension. By inserting the combo wire into the pulmonary artery, pressure and flow velocity are measured simultaneously. These measurements are then calculated using the Wave Intensity and Water Hammer equation formulas to isolate and quantify the pulmonary artery waveform into forward and reflected waves. On the same day, prior to the catheterization, study collaborators perform an echocardiogram to estimate forward and reflected waves using a similar method based on the Doppler-derived right ventricular outflow tract waveform and tricuspid regurgitation waveform. The study aims to compare and correlate the pulmonary artery isolated wave pressure obtained via the combo wire catheter with that derived from the echocardiogram Doppler method.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have provided written consent to participate in the study
2. Men and women who are 20 years of age or older at the time of consent acquisition
3. Patients scheduled for right heart catheterization due to suspicion of pulmonary hypertension
Key exclusion criteria
Patients deemed inappropriate for participation in this study by the principal (co-)investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hisao |
| Middle name | |
| Last name | Hara |
Organization
National Center for Global Health and Medicine
Division name
Cardiology
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
0332027181
hhayama@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Hisao |
| Middle name | |
| Last name | Hara |
Organization
National Center for Global Health and Medicine
Division name
Cardiology
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
0332027181
Homepage URL
hhara@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
International Medical Research and Development Expenses
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine Clinical Research Center
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel
0332027181
kenkyu-shinsa@hosp.ncgm.go.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 | 04 | Month | 09 | 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
14
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 24 | 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 | 04 | Month | 09 | Day |
Last modified on
| 2024 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061783
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| Registered date | File name |
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