UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049092 |
|---|---|
| Receipt number | R000055838 |
| Scientific Title | A prospective observational study for clarifying the pathophysiology of chronic thromboembolic pulmonary hypertension via analyzing the genome and transomics analyses. |
| Date of disclosure of the study information | 2022/10/03 |
| Last modified on | 2022/10/02 21:56:07 |
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Basic information
Public title
Study of chronic thromboembolic pulmonary hypertension via analyzing the genome and transomics analyses.
Acronym
The genome and transomics analyses of chronic thromboembolic pulmonary hypertension.
Scientific Title
A prospective observational study for clarifying the pathophysiology of chronic thromboembolic pulmonary hypertension via analyzing the genome and transomics analyses.
Scientific Title:Acronym
The genome and transomics analyses of chronic thromboembolic pulmonary hypertension.
Region
| Japan |
Condition
Condition
chronic thromboembolic pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the pathophysiology of chronic thromboembolic pulmonary hypertension via examining genome and transomics analyses.
Basic objectives2
Others
Basic objectives -Others
To investigate the involvement of somatic cell gene mutation in the pathophysiology of chronic thromboembolic pulmonary hypertension
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The involvement of somatic gene mutation in the pathophysiology of chronic thromboembolic pulmonary hypertension.
Key secondary outcomes
Epigenome, transcriptome, and proteome data of the lesions. Plasma metabolome data.
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
Hospitalized patients of chronic thromboembolic pulmonary hypertension. hospitalized patients who have atrial fibrillation or deep vein thrombosis as a control group.
Key exclusion criteria
Patients with HBV, HCV or HIV virus, patients under using prednisolone, cancer patients under treatment or patients who have history of cancer, patients with psychosis having trouble to get consent form, or patients with dementia who need treatment.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Yamashita |
Organization
Kobe University Hospital
Division name
Division of Cardiovascular medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5846
tomoya@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Yamashita |
Organization
Kobe University Hospital
Division name
Division of Cardiovascular medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL
078-382-5846
Homepage URL
tomoya@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Agency for Medical Research and Development
IRB Contact (For public release)
Organization
Kobe University Hospital, Medical Ethics Review Board
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-382-5400
kansatsu@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
神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional observation study. Only in-hospital for entry and observation.
Management information
Registered date
| 2022 | Year | 10 | Month | 02 | Day |
Last modified on
| 2022 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055838
