UMIN-CTR Clinical Trial

Basic information
Public title	The prospective observational study of tissue characterization and information of genome and gene in patients with chronic thromboembolic pulmonary hypertension
Acronym	Pulmonary artery intima analysis
Scientific Title	The prospective observational study of tissue characterization and information of genome and gene in patients with chronic thromboembolic pulmonary hypertension
Scientific Title:Acronym	Analysis of pulmonary artery intima by single cell RNA sequencing
Region	Japan

Condition
Condition	Chronic thromboembolic pulmonary hypertension
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the characterization of pulmonary artery intima and organized thrombus by single-cell RNA sequencing
Basic objectives2	Others
Basic objectives -Others	Examine contributing factors in chronic thromboembolic pulmonary hypertension by comparing characterization of pulmonary artery intima and organized thrombus with thrombosis risk.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of single cell gene expression of the pulmonary artery intima and organized thrombus in patients with chronic thromboembolic pulmonary hypertension undergoing pulmonary endarterectomy.
Key secondary outcomes	Relationship between various data of pulmonary artery intima and data of blood sample in patients with chronic thromboembolic pulmonary hypertension undergoing pulmonary endarterectomy. 1. bulk RNA sequencing 2. exosome analysis 3. histological evaluation 4. single cell ATAC sequencing 5. single cell RNA sequencing of blood sample 6. exosome analysis of blood sample

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 is undergoing pulmonary endarterectomy for Chronic thromboembolic pulmonary hypertension. (2) patients 20 years of age or older when we get consent form. (3) Patients for whom written consent has been obtained by the individual.
Key exclusion criteria	(1) Patients suffering from hepatitis B and C viruses and human immunodeficiency virus. (2) Other patients who are deemed inappropriate by the physician in charge of the study.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Taniguchi
Organization	Kobe University Hospital
Division name	The division of Cardiovascular medicine
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Kobe, Hyogo, Japan
TEL	078-382-5846
Email	yu.taniguchi007@gmail.com

Public contact
Name of contact person	1st name Yu Middle name Last name Taniguchi
Organization	Kobe University Hospital
Division name	The division of Cardiovascular medicine
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Kobe, Hyogo, Japan
TEL	078-382-5846
Homepage URL
Email	yu.taniguchi007@gmail.com

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	Kobe University Hospital/Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Hospital
Address	7-5-2, Kusunoki-cho, Kobe, Hyogo, Japan
Tel	078-382-5111
Email	chiken@med.kobe-u.ac.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	2022 Year 04 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 12 Month 22 Day
Date of IRB	2021 Year 12 Month 23 Day
Anticipated trial start date	2021 Year 12 Month 23 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study

Management information
Registered date	2022 Year 04 Month 18 Day
Last modified on	2022 Year 04 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054195