UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022247 |
|---|---|
| Receipt number | R000025632 |
| Scientific Title | Echocardiographic Predictors of Mortality and Length of Stay in Hospital in Patients with Major Elective Non-cardiac Surgery |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2021/05/13 09:30:35 |
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Basic information
Public title
Echocardiographic Predictors of Mortality and Length of Stay in Hospital in Patients with Major Elective Non-cardiac Surgery
Acronym
Echocardiography and Surgical mortality
Scientific Title
Echocardiographic Predictors of Mortality and Length of Stay in Hospital in Patients with Major Elective Non-cardiac Surgery
Scientific Title:Acronym
Echocardiography and Surgical mortality
Region
| Japan |
Condition
Condition
Patients with major elective non-cardiac surgery
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim of this study was to find the association of echocardiography before major elective non-cardiac surgery with survival and length of hospital stay in patients without known cardiovascular disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
aged over 50 years who had resting echocardiography within 3 months before surgery. We have excluded patients who had known cardiovascular disease. Hospital mortality and length of stay in hospital were gathered.
Key exclusion criteria
No commitment.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenya Kusunose |
Organization
Tokushima University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
Kuramoto 3-18-15
TEL
088-633-7851
kusunosek@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Clinical Trial Center For Development Therapeutics |
Organization
Tokushima University Hospital
Division name
Clinical Trial Center
Zip code
Address
Kuramoto 2-50-1
TEL
088-633-9294
Homepage URL
awachiken@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
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
| 2016 | Year | 07 | Month | 01 | 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
| 2016 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 11 | Month | 25 | Day |
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 05 | Month | 09 | Day |
Last modified on
| 2021 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025632
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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