臨床研究等提出・公開システム

Date of registration	Dec. 29, 2022
Last modified on	Dec. 29, 2022
Trial ID	jRCT1030220553

Scientific Title	Evaluation of microvasculr dysfunction in chronic thromboembolic pulmonary hypertension
Public Title	Evaluation of microvasculr dysfunction in CTEPH

Contact for Scientific Queries	Name	Sato Shuji
	Affiliation	Toho University Sakura Medical Center
	Address	Shimoshizu 564-1, Sakura city, Chiba prefecture
	Telephone	+81-43-462-8811
	E-mail	shuuji.satou@med.toho-u.ac.jp
Contact for Public Queries	Name	Shuji Sato
	Affiliation	Toho University Sakura Medical Center
	Address	Shimoshizu 564-1, Sakura city, Chiba prefecture
	Telephone	+81-43-462-8811
	E-mail	shuuji.satou@med.toho-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 29, 2022
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic desease (CTED) who underwent balloon pulmonary angioplasty (BPA) in our institution.
	Exclusion Criteria	None
	Age Minimum	16age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		chronic thromboembolic pulmonary hypertension (CTEPH), chronic thromboembolic desease (CTED)
Intervention(s)		A pressure wire is used to measure the pulmonary microcirculatory indices based on the principle of thermodilution method. In addition to the ordinal therapeutic manipulation, 3 ml of saline injection into the local pulmonary artery is required. In addition, nitric oxide (NO) inhalation is required to examine pulmonary microvascular dilatation.
Primary Outcome(s)		A pressure wire allows the measurement of mean transit time (Tmn) using the principle of thermodilution method. In addition, nitric oxide (NO) inhalation is used to induce hyperemia and assess pulmonary microvascular dilatation. Local pulmonary artery pressure and Tmn are used to calculate and assess the following pulmonary microcirculatory indices. Vascular flow reserve (VFR) = Resting Tmn/Hyperemic Tmn Index of microcirculatory resistance (IMR) = Distal pulmonary artery pressure/1/Resting Tmn Resistive reserve ratio (RRR) = Resting IMR/Hyperemic IMR

Primary Sponsor	Toho University Sakura Medical Center

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Toho University Medical Center Sakura Hospital Ethics Committee
Address	Shimoshizu 564-1, Sakura city, chiba prefecture, Chiba
Telephone	+81-434628811
E-Mail	sakura.rinri@ext.toho-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 14, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none