UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese Study of Impact of Body Mass Index on Morbidity and Mortality in Geriatric Patients Part 1: Coronary Artery Bypass Grafting
Title of the study (Brief title)	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	Naritomo Nishioka
Organization	The Jikei University Graduate School of Medicine
Division name	Department of Cardiac Surgery
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	Naritomo Nishioka
Organization	The Jikei University Graduate School of Medicine
Division name	Department of Cardiac Surgery
Address	3-25-8,Nishi-shimbashi,MInato-ku,Tokyo,Japan
TEL	(03)3433-1111
Homepage URL
Email	naritomo.n@jikei.ac.jp

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

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 11 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028819