UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039126
Receipt number 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 14:00:03

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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 or person

Institute

The Jikei University Kashiwa Hospital

Institute

Department

Personal name



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

Value
https://center6.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