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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name