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

JRCT ID: jRCTs062180098

Registered date:22/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pulmonary stenosis, pulmonary hypertension(congenital heart disease)
• Date of first enrollment: 12/06/2018
• Target sample size: 10
• Study type: Interventional

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 Outcome: To evaluate histological change in pulmonary vessels in pulmonary stenosis or pulmonary hypertension in pulmonary stenosis.
• Secondary Outcome: Compare to other modalities(intravascular ultrasound or CT)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 15age old
• Gender: Both

Include criteria

Congenital heart disease patients with pulmonary stenosis or pulmonary hypertension
Body weight>6kg

• Exclude criteria: Patients with bad condition/ Patients with chromosome abnomality(except 21 trisomy)

Related Information

• Primary Sponsor: Takata Hidemi