UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020924
Receipt number R000024140
Scientific Title Study in differences of cardiac tissue or cardiac stem cells among patients
Date of disclosure of the study information 2016/02/08
Last modified on 2021/02/12 00:46:29

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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 or person

Institute

Juntendo University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024140


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name