UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011187 |
|---|---|
| Receipt number | R000013106 |
| Scientific Title | Relation between serum glycated albumin levels and atherosclerosis in patients undergoing surgery |
| Date of disclosure of the study information | 2013/07/14 |
| Last modified on | 2013/07/14 00:36:45 |
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Basic information
Public title
Relation between serum glycated albumin levels and atherosclerosis in patients undergoing surgery
Acronym
Glycated albumin in patients undergoing surgery
Scientific Title
Relation between serum glycated albumin levels and atherosclerosis in patients undergoing surgery
Scientific Title:Acronym
Glycated albumin in patients undergoing surgery
Region
| Japan |
Condition
Condition
All adult patients who undergo surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Oto-rhino-laryngology |
| Orthopedics | Urology | Anesthesiology |
| Oral surgery | Neurosurgery | Cardiovascular surgery |
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether serum glycated albumin (GA) levels are a useful preoperative risk factor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
past history, complications, laboratory findings, surgical procedures, and postoperative course
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
all adult patients who undergo surgery
Key exclusion criteria
patients who undergo emergency operation
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makiko Komori |
Organization
Medical Center East, Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
Address
2-1-10, Nishiogu, Arakawa-ku, Tokyo, 116-8567
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Medical Center East, Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
Address
2-1-10, Nishiogu, Arakawa-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology, Medical Center East, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Medical Center East, Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 07 | Month | 14 | 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
| 2012 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with high GA levels had significantly increased incidences of coronary heart disease and cerebrovascular disease.
Management information
Registered date
| 2013 | Year | 07 | Month | 14 | Day |
Last modified on
| 2013 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013106
