UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036618 |
|---|---|
| Receipt number | R000041719 |
| Scientific Title | PD-1/PD-L1 on cardiovascular diseases |
| Date of disclosure of the study information | 2019/04/27 |
| Last modified on | 2020/08/02 16:51:34 |
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Basic information
Public title
The relation between Programmed death-1 (PD-1)/Programmed death-ligand 1 (PD-L1) and cardiovascular diseases
Acronym
PD-1/PD-L1 on cardiovascular diseases
Scientific Title
PD-1/PD-L1 on cardiovascular diseases
Scientific Title:Acronym
PD-1/PD-L1 on cardiovascular diseases
Region
| Japan |
Condition
Condition
Cardiovascular diseases (myocardial infarction, angina, heart failure, arrhythmia, peripheral artery disease, aortic dissection, and aneurysm)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the relation between PD-1/PD-L1 and cardiovascular diseases.
Basic objectives2
Others
Basic objectives -Others
Pathophisiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) The assessment of serum levels of PD-1 and PD-L1 in the pathophysiological findings in patients with cardiovascular diseases.
2) The association between PD-1 and PD-L1, and cardiovascular outcomes in patients with cardiovascular diseases.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria is all patients admitted Kumamoto University Hospital due to diagnosis or treatment for their cardiovascular diseases.
Key exclusion criteria
ACS cohort
1) Patients who do not consent for this study.
2) active malignancy
3) hemodialysis
4) active systemic inflammatory diseases (autoimmune diseases, rheumatoid diseases required immunosuppression therapies, and severe infectious diseases)
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Kumamoto University
Division name
Department of Cardiovascular Medicine, Graduate School of Medical Sciences
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
TEL
81-96-373-5175
tsujita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Fujisue |
Organization
Kumamoto University
Division name
Department of Cardiovascular Medicine Graduate School of Medical Sciences
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
TEL
81-96-373-5175
Homepage URL
fujisues@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Ethics Review Committee of Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
Tel
81-96-373-5657
byi-senshin@jimu.kumamoto-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
| 2019 | Year | 04 | Month | 27 | 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
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement and comparison of blood levels of PD-1 and PD-L1.
Management information
Registered date
| 2019 | Year | 04 | Month | 27 | Day |
Last modified on
| 2020 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041719
