UMIN-CTR Clinical Trial

Basic information
Public title	Study in differences of cardiac tissue or cardiac stem cells among patients
Acronym	Study in differences of cardiac tissue
Scientific Title	Study in differences of cardiac tissue or cardiac stem cells among patients
Scientific Title:Acronym	Study in differences of cardiac tissue
Region	Japan

Condition
Condition	cardiovascular diseases
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the factor(s) affecting the cardiac tissue or cardiac stem cells
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	gene expression(s)
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	20 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent cardiocvascular surgery
Key exclusion criteria	redo case irradiated
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Matsushita
Organization	Juntendo University
Division name	Department of Cardiovascular Surgery
Zip code	1138421
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	saty-m@juntendo.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Matsushita
Organization	Juntendo University
Division name	Department of Cardiovascular Surgery
Zip code	1138421
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	saty-m@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Department of Cardiovascular Surgery
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	Juntendo University
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
Tel	03-3813-3111
Email	saty-m@juntendo.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	2016 Year 02 Month 08 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	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 22 Day
Date of IRB	2016 Year 01 Month 29 Day
Anticipated trial start date	2016 Year 02 Month 08 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	Cohort study Recruitment: Patients whose cardiac tissue obtained during surgery.

Management information
Registered date	2016 Year 02 Month 08 Day
Last modified on	2021 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024140