UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041255
Receipt number R000047112
Scientific Title Differences between atherosclerotic and non-atherosclerotic patients in expression levels of inflammatory mediators in the adipose tissue around the coronary artery
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/30 10:24:25

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Basic information

Public title

Differences between atherosclerotic and non-atherosclerotic patients in expression levels of inflammatory mediators in the adipose tissue around the coronary artery

Acronym

PVAT effect for atherosclerosis

Scientific Title

Differences between atherosclerotic and non-atherosclerotic patients in expression levels of inflammatory mediators in the adipose tissue around the coronary artery

Scientific Title:Acronym

PVAT effect for atherosclerosis

Region

Japan


Condition

Condition

atherosclerotic patients

Classification by specialty

Cardiology Endocrinology and Metabolism Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Perivascular adipose tissue secretes large amounts of inflammatory mediators and plays a certain role in atherosclerosis formation from the exterior.

Basic objectives2

Others

Basic objectives -Others

In the present study, we examined the expression level of inflammation-related mediators using adipose tissue samples harvested from patients with and without coronary artery disease.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

In the present study, we examined the expression level of inflammation-related mediators using adipose tissue samples harvested from patients with and without coronary artery disease.

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

30 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

patient underwent CABG

Key exclusion criteria

non elective CABG patients

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Tomoaki
Middle name
Last name Suzuki

Organization

Shiga university of medical science

Division name

cardiovascular surgery

Zip code

525-2192

Address

setatsukinowatyou

TEL

077-548-2241

Email

suzukit@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name Tomoaki
Middle name
Last name Suzuki

Organization

Shiga university of medical science

Division name

cardiovascular surgery

Zip code

525-2192

Address

setatsukinowatyou

TEL

077-548-2241

Homepage URL


Email

suzukit@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga university of medical science

Institute

Department

Personal name



Funding Source

Organization

Shiga university of medical science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiga university of medical science

Address

setatsukinowatyou,otsu

Tel

077-548-2241

Email

suzukit@balle.shiga-med.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

2020 Year 08 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

40

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

Main results already published

Date of protocol fixation

2017 Year 10 Month 01 Day

Date of IRB

2017 Year 12 Month 31 Day

Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

non


Management information

Registered date

2020 Year 07 Month 30 Day

Last modified on

2020 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047112


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name