UMIN-CTR Clinical Trial

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
Email	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
Email	k.minami@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048782