UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044661 |
|---|---|
| Receipt number | R000050655 |
| Scientific Title | Clinical implication of body mass index in patients undergoing cardiac revascularization for acute myocardial infarction: Comparison of ST-elevation and non-ST-elevation myocardial infarction |
| Date of disclosure of the study information | 2021/06/25 |
| Last modified on | 2024/06/27 09:33:50 |
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Basic information
Public title
Clinical implication of body mass index in patients with acute myocardial infarction
Acronym
Clinical implication of body mass index in patients with acute myocardial infarction
Scientific Title
Clinical implication of body mass index in patients undergoing cardiac revascularization for acute myocardial infarction: Comparison of ST-elevation and non-ST-elevation myocardial infarction
Scientific Title:Acronym
Clinical implication of body mass index in patients undergoing cardiac revascularization for acute myocardial infarction: Comparison of ST-elevation and non-ST-elevation myocardial infarction
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Despite smaller infarct size and lower rate of coronary occlusion, worse prognosis is shown in patients with NSTEMI compared to those with STEMI. This is because geriatric condition may be strongly associated with long-term prognosis rather than cardiac damage. The aim of this study is to investigate the prognostic difference of body mass index in patients with ST- and non-ST-elevation myocardial infarction.
Basic objectives2
Others
Basic objectives -Others
Clinical implication of muscle wasting calculated by height, weight, age, and gender in patients with acute myocardial infarction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiovascular events including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke
Key secondary outcomes
All-cause death
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients hospitalized with acute myocardial infarction
2) Patients undergoing coronary angiography
3) Patients undergoing revascularization including percutaneous coronary intervention or coronary artery bypass graft during hospitalization
Key exclusion criteria
1) Patients with out-of-hospital cardiac arrest
2) Lacking of height and body weight on admission in medical record
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kindai University
Division name
Department of Cardiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osakasayama
TEL
+81723660221
kmatsumura1980@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kindai University
Division name
Department of Cardiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osakasayama
TEL
+81723660221
Homepage URL
kmatsumura1980@yahoo.co.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kenichi Fujii, Department of Cardiology, Kansai Medical University
Hiroshi Matsumoto, Department of Cardiology, Kansai Medical University Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University
Address
377-2, Ohnohigashi, Osakasayama
Tel
+81723660221
kmatsumura1980@yahoo.co.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
近畿大学病院（大阪府大阪狭山市）、関西医科大学附属病院（大阪府枚方市）、関西医科大学総合医療センター（大阪府守口市）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 25 | 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
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
Terminated
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Patient prognosis was obtained by medical record or sending questionnaire to follow-up hospital
Appendicular skeletal muscle mass was estimated according to height, body weight, age and gender using an anthropometric equation previously validated in Asian populations
Muscle wasting was defined as skeletal muscle index (appendicular skeletal muscle mass(kg)/height(m)/height(m))<7.0kg/m2 in men and <5.4kg/m2 in women according to AWGS guideline 2019
Management information
Registered date
| 2021 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050655
