UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025042
Receipt number R000028819
Scientific Title Japanese Study of Impact of Body Mass Index on Morbidity and Mortality in Geriatric Patients Part 1: Coronary Artery Bypass Grafting
Date of disclosure of the study information 2016/12/01
Last modified on 2018/06/01 18:14:54

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Basic information

Public title

Japanese Study of Impact of Body Mass Index on Morbidity and Mortality in Geriatric Patients Part 1: Coronary Artery Bypass Grafting

Acronym

jAIM study-1

Scientific Title

Japanese Study of Impact of Body Mass Index on Morbidity and Mortality in Geriatric Patients Part 1: Coronary Artery Bypass Grafting

Scientific Title:Acronym

jAIM study-1

Region

Japan


Condition

Condition

Coronary artery disease
(myocardial infarction, angina pectoris)

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study was to investigate the relationship between body mass index (BMI) and early morbidity and mortality
for elderly patients with CABG using the National Clinical Database (NCD) in Japan.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

early mortality (in-hospital mortality + 30-day mortality)

Key secondary outcomes

the composite endpoint (adverse events), including early mortality, stroke, new onset of hemodialysis, mediastinitis, and prolonged ventilation over 24h


Base

Study type

Others,meta-analysis etc


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

60 years-old <=

Age-upper limit

99 years-old >

Gender

Male and Female

Key inclusion criteria

The NCD was utilized to perform a retrospective review of 37,775 patients who underwent CABG between 1/1/2008 and 12/31/2012.

Key exclusion criteria

Exclusion criteria is to include valve surgery,aortic surgery, LV plasty, and Maze procedure.

Target sample size

37775


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naritomo Nishioka

Organization

The Jikei University Graduate School of Medicine

Division name

Department of Cardiac Surgery

Zip code


Address

3-25-8,Nishi-shimbashi,MInato-ku,Tokyo,Japan

TEL

(03)3433-1111

Email

naritomo.n@jikei.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naritomo Nishioka

Organization

The Jikei University Graduate School of Medicine

Division name

Department of Cardiac Surgery

Zip code


Address

3-25-8,Nishi-shimbashi,MInato-ku,Tokyo,Japan

TEL

(03)3433-1111

Homepage URL


Email

naritomo.n@jikei.ac.jp


Sponsor or person

Institute

Department of Cardiac Surgery, The Jikei University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiac Surgery, The Jikei University Graduate School of Medicine

The Jikei University Research Fund for Graduate Students in 2017.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Healthcare Quality Assessment, Graduate School of Medicine, The University of Tokyo,
Department of Health Policy and Management, School of Medicine, Keio University,
Department of Cardiology, Keio University School of Medicine,
Japan Adult Cardiovascular Surgery Database

Name of secondary funder(s)

The Japanese Society for Cardiovascular Surgery
(The Japan Adult Cardiovascular Surgery Database Clinical Investigation Project Award in 2017)


IRB Contact (For public release)

Organization


Address


Tel


Email



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

東京慈恵会医科大学(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Emaciation (BMI<18.5) was associated with increased risks of operative mortality while obesity (BMI>30)was the primary risks for early combined morbidity for elderly patients who underwent CABG.

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

2016 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information

This clinical research is a retrospective
cohort study.There is no opportunity of adverse events or side effects for the patients.

There is no conflict of interest.


Management information

Registered date

2016 Year 11 Month 29 Day

Last modified on

2018 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028819


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name