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
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
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
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
