UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043273 |
|---|---|
| Receipt number | R000048782 |
| Scientific Title | Survey of frailty status in elderly patients undergoing cardiovascular surgery |
| Date of disclosure of the study information | 2021/02/10 |
| Last modified on | 2021/02/07 16:24:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey of frailty status in elderly patients undergoing cardiovascular surgery
Acronym
Survey of frailty status in elderly patients undergoing cardiovascular surgery
Scientific Title
Survey of frailty status in elderly patients undergoing cardiovascular surgery
Scientific Title:Acronym
Survey of frailty status in elderly patients undergoing cardiovascular surgery
Region
| Japan |
Condition
Condition
Cardiovascular Diseases
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the trajectory of flail due to cardiovascular surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in frailty associated with surgery in elderly patients undergoing cardiovascular surgery, from 1 month preoperatively to 3 months postoperatively.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 65 years old scheduled for cardiovascular surgery.
Key exclusion criteria
Patients with complications of dementia that interfere with daily life
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Koya |
| Middle name | |
| Last name | Shimakura |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesiology
Zip code
564-8565
Address
6-1 Kishibe Shinmachi, Suita, Osaka
TEL
06-6170-1070
shimakura.koya@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Kimito |
| Middle name | |
| Last name | Minami |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Surgical Intensive Care
Zip code
564-8565
Address
6-1 Kishibe Shinmachi, Suita, Osaka
TEL
06-6170-1070
Homepage URL
k.minami@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
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
he Ethics Committee of National Cerebral and Cardiovascular Center
Address
6-1 Kishibe Shinmachi, Suita, Osaka
Tel
06-6170-1070
shimakura.koya@ncvc.go.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
| 2021 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
To be announced at a later date
Publication of results
Partially published
Result
URL related to results and publications
To be announced at a later date
Number of participants that the trial has enrolled
79
Results
To be announced at a later date
Results date posted
| 2020 | Year | 12 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
To be announced at a later date
Participant flow
To be announced at a later date
Adverse events
To be announced at a later date
Outcome measures
To be announced at a later date
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of the trajectory of frailty due to cardiovascular surgery
Management information
Registered date
| 2021 | Year | 02 | Month | 07 | Day |
Last modified on
| 2021 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048782
