UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029848 |
|---|---|
| Receipt number | R000034090 |
| Scientific Title | Prognostic impact of nutritional status in patients undergoing endvascular therapy |
| Date of disclosure of the study information | 2017/11/10 |
| Last modified on | 2020/02/12 12:51:40 |
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Basic information
Public title
Prognostic impact of nutritional status in patients undergoing endvascular therapy
Acronym
Prognostic impact of nutritional status in patients undergoing endvascular therapy
Scientific Title
Prognostic impact of nutritional status in patients undergoing endvascular therapy
Scientific Title:Acronym
Prognostic impact of nutritional status in patients undergoing endvascular therapy
Region
| Japan |
Condition
Condition
Peripheral artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to determine the prognostic impact of CONUT score in patients with PAD undergoing endovascular therapy (EVT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
any death
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
Patients who received endovascular therapy in Tokyo Women's Medical University between 2013 and 2017.
Key exclusion criteria
We excluded patients without full laboratory data.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Hagiwara |
Organization
Tokyo Women's Medical University
Division name
Cardiology
Zip code
Address
8-1 Kawadacho Sinjyukuku Tokyo Japan
TEL
03-3353-8111
key.co.512@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Mizobuchi |
Organization
Tokyo Women's Medical University
Division name
Cardiology
Zip code
Address
8-1 Kawadacho Sinjyukuku Tokyo Japan
TEL
03-3353-8111
Homepage URL
key.co.512@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 10 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CONUT score, as a nutritional status, that was calculated by lymphocyte numbers, serum albumin and total cholesterol levels in patients undergoing EVT was associated with any death.
Management information
Registered date
| 2017 | Year | 11 | Month | 06 | Day |
Last modified on
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034090
