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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs062180098

Registered date:22/03/2019

Stenotic lesion in patients with congenital heart disease using optical coherence tomography(OCT)

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPulmonary stenosis, pulmonary hypertension(congenital heart disease)
Date of first enrollment12/06/2018
Target sample size10
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)The subjects are patients with pulmonary stenosis or pulmonary hypertension in congenital heart disease, they are planned cardiac catheter examination. After routine catheter examination, we are going to evaluate the histological changes using optical coherence tomography.

Outcome(s)

Primary OutcomeTo evaluate histological change in pulmonary vessels in pulmonary stenosis or pulmonary hypertension in pulmonary stenosis.
Secondary OutcomeCompare to other modalities(intravascular ultrasound or CT)

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum<= 15age old
GenderBoth
Include criteriaCongenital heart disease patients with pulmonary stenosis or pulmonary hypertension Body weight>6kg
Exclude criteriaPatients with bad condition/ Patients with chromosome abnomality(except 21 trisomy)

Related Information

Contact

Public contact
Name Hidemi Takata
Address Shitsukawa, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5320
E-mail hidemi.takata@gmail.com
Affiliation Ehime University Graduate School of Medicine
Scientific contact
Name Hidemi Takata
Address Shitsukawa, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5320
E-mail hidemi.takata@gmail.com
Affiliation Ehime University Graduate School of Medicine