UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044006
Receipt number R000050237
Scientific Title Study on establishment of screening method for sarcopenia in patients with cardiovascular risk and its application to risk stratification of cardiovascular event.
Date of disclosure of the study information 2021/04/21
Last modified on 2021/04/21 19:34:20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study on establishment of screening method for sarcopenia in patients with cardiovascular risk and its application to risk stratification of cardiovascular event.

Acronym

Establishment of predictive indicator for cardiovascular event using simple sarcopenia screening method.

Scientific Title

Study on establishment of screening method for sarcopenia in patients with cardiovascular risk and its application to risk stratification of cardiovascular event.

Scientific Title:Acronym

Establishment of predictive indicator for cardiovascular event using simple sarcopenia screening method.

Region

Japan


Condition

Condition

cardiovascular disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the prediction ability of simple screening method for sarcopenia for cardiovascular events.

Basic objectives2

Others

Basic objectives -Others

Evaluation of the predictive ability for adverse events.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Composite of cardiovascular events

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients calculated simple screening score for sarcopenia

Key exclusion criteria

Nothing

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kenichi
Middle name
Last name Tsujita

Organization

Kumamoto University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

860-8556

Address

1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto-ken

TEL

+81963735175

Email

tsujita@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name Shinsuke
Middle name
Last name Hanatani

Organization

Kumamoto University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

860-8556

Address

1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto-ken

TEL

+81963735175

Homepage URL


Email

s-hanata@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

Kumamoto University

Address

1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto-ken

Tel

+81963735175

Email

s-hanata@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

2021 Year 04 Month 21 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

1218

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

No longer recruiting

Date of protocol fixation

2012 Year 01 Month 01 Day

Date of IRB

2017 Year 07 Month 06 Day

Anticipated trial start date

2012 Year 01 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Follow-up of cardiovascular events


Management information

Registered date

2021 Year 04 Month 21 Day

Last modified on

2021 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050237


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name