Unique ID issued by UMIN | UMIN000054098 |
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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 |
Establishment of a method for isolating pulmonary artery waveform non-invasively
Establishment of a method for isolating pulmonary artery waveform non-invasively
Establishment of a method for isolating pulmonary artery waveform non-invasively
Establishment of a method for isolating pulmonary artery waveform non-invasively
Japan |
Patients suspected of having pulmonary hypertension
Cardiology |
Others
NO
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.
Bio-equivalence
Comparison of estimated pulmonary artery isolated wave pressure obtained using a combo wire catheter and echocardiogram Doppler method
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Prevention
Device,equipment |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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
Patients deemed inappropriate for participation in this study by the principal (co-)investigator.
30
1st name | Hisao |
Middle name | |
Last name | Hara |
National Center for Global Health and Medicine
Cardiology
162-8655
1-21-1 Toyama, Shinjuku-ku, Tokyo
0332027181
hhayama@hosp.ncgm.go.jp
1st name | Hisao |
Middle name | |
Last name | Hara |
National Center for Global Health and Medicine
Cardiology
162-8655
1-21-1 Toyama, Shinjuku-ku, Tokyo
0332027181
hhara@hosp.ncgm.go.jp
National Center for Global Health and Medicine
International Medical Research and Development Expenses
Japanese Governmental office
National Center for Global Health and Medicine Clinical Research Center
1-21-1 Toyama, Shinjuku-ku, Tokyo
0332027181
kenkyu-shinsa@hosp.ncgm.go.jp
NO
2024 | Year | 04 | Month | 09 | Day |
Published
14
No adverse events
Completed
2020 | Year | 06 | Month | 26 | Day |
2020 | Year | 06 | Month | 26 | Day |
2020 | Year | 06 | Month | 26 | Day |
2024 | Year | 03 | Month | 24 | Day |
2024 | Year | 04 | Month | 09 | Day |
2024 | Year | 04 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061783
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