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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000039126
Receipt No. R000044622
Scientific Title Sarcopenia aneurysm scoring system predicts early and midterm mortality after endovascular repair for abdominal aortic aneurysm
Date of disclosure of the study information 2020/12/31
Last modified on 2021/01/10

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Basic information
Public title Sarcopenia aneurysm scoring system predicts early and midterm mortality after endovascular repair for abdominal aortic aneurysm
Acronym Sarcopenia aneurysm scoring system for EVAR
Scientific Title Sarcopenia aneurysm scoring system predicts early and midterm mortality after endovascular repair for abdominal aortic aneurysm
Scientific Title:Acronym Sarcopenia aneurysm scoring system for EVAR
Region
Japan

Condition
Condition Abdominal aortic aneurysm
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We developed a new scoring system with sarcopenic factor and preoperative patient characteristics and morphological features of AAA to predict overall mortality after elective EVAR
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes All-cause mortality
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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria The patients with EVAR for AAA
Key exclusion criteria Ruptured AAA
Isolated iliac aneurysm
Target sample size 310

Research contact person
Name of lead principal investigator
1st name Eisaku
Middle name
Last name Ito
Organization The Jikei University school of medicine
Division name Vascular surgery
Zip code 277-8567
Address 163-1, Kashiwashita, Kashiwa-city
TEL 0471641111
Email i_eisaku_ukasie@yahoo.co.jp

Public contact
Name of contact person
1st name Eisaku
Middle name
Last name Ito
Organization The Jikei University Kashiwa Hospital
Division name Vascular surgery
Zip code 277-8567
Address 163-1, Kashiwashita, Kashiwa-city
TEL 0471641111
Homepage URL
Email i_eisaku_ukasie@yahoo.co.jp

Sponsor
Institute The Jikei University Kashiwa Hospital
Institute
Department

Funding Source
Organization KAKENHI
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 The Jikei University Kashiwa Hospital
Address 163-1, Kashiwashita, Kashiwa-city
Tel 0471641111
Email i_eisaku_ukasie@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

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 31 Day

Related information
URL releasing protocol https://insights.ovid.com/pubmed?pmid=33002942
Publication of results Published

Result
URL related to results and publications https://insights.ovid.com/pubmed?pmid=33002942
Number of participants that the trial has enrolled 310
Results In a multivariate analysis, age, aneurysm diameter, eGFR, and PMI were associated with all-cause mortality. The SAS system was defined as the sum of the following factors: elderly (75 years), large aneurysm (65 mm), low eGFR (30 mL/min/1.73 m), and low PMI (males: 48.2 cm/m, females: 36.8 cm/m). We compared the SAS with the other prognostic scoring for 5-year mortality(GAS: 0.731, mLS: 0. 718, CSS: 0. 646, ES: 0.661, and SAS: 0.785, P = 0.013).
Results date posted
2021 Year 01 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Elective endovascular repair for abdominal aortic aneurysm
Participant flow Retrospective observational study
Adverse events None
Outcome measures All cause death
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
2018 Year 12 Month 10 Day
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2020 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information None

Management information
Registered date
2020 Year 01 Month 10 Day
Last modified on
2021 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044622

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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