UMIN-CTR Clinical Trial

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
Email	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
Email	fujisues@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041719