Establishment of a method for isolating pulmonary artery waveform non-invasively

UMIN ID: UMIN000054098

Registered date:09/04/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients suspected of having pulmonary hypertension
• Date of first enrollment: 2020/06/26
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Comparison of estimated pulmonary artery isolated wave pressure obtained using a combo wire catheter and echocardiogram Doppler method

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients deemed inappropriate for participation in this study by the principal (co-)investigator.

Related Information

• Primary Sponsor: National Center for Global Health and Medicine
• Source(s) of Monetary Support: International Medical Research and Development Expenses