UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054563 |
|---|---|
| Receipt number | R000062330 |
| Scientific Title | A study of the relationship between postoperative glycemic control and cardiac autonomic nervous activity |
| Date of disclosure of the study information | 2024/06/08 |
| Last modified on | 2025/12/05 10:59:31 |
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Basic information
Public title
A study of the relationship between postoperative glycemic control and cardiac autonomic nervous activity
Acronym
Relationship between postoperative glycemic control and cardiac autonomic nervous activity
Scientific Title
A study of the relationship between postoperative glycemic control and cardiac autonomic nervous activity
Scientific Title:Acronym
Relationship between postoperative glycemic control and cardiac autonomic nervous activity
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiovascular surgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between postoperative glycemic control and preoperative cardiac autonomic nervous activity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preoperative autonomic nervous activity and postoperative glycemic control
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cardiovascular surgery
Key exclusion criteria
1. Patients undergoing emergency surgery
2. Patients with pacemaker
3. Patients with ventricular assist device
4. Patients underwent cardiac transplantation
5. Patients with frequent arrhythmia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kawamoto |
Organization
Tohoku medical and pharmaceutical university, Faculty of medicine
Division name
Division of cardiovascular surgery
Zip code
983-8536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai, Japan
TEL
022-290-8970
kawamoto@tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Kamakura |
Organization
Tohoku medical and pharmaceutical university, Faculty of medicine
Division name
Division of cardiovascular surgery
Zip code
983-8536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai, Japan
TEL
022-290-8850
Homepage URL
miho_kamakura_16@yahoo.co.jp
Sponsor or person
Institute
Tohoku medical and pharmaceutical university
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology: Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of tohoku medical and pharmaceutical university hospital
Address
1-12-1 Fukumuro, Miyagino-ku, Sendai, Japan
Tel
022-259-1221
research@hosp.tohoku-mpu.ac.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
| 2024 | Year | 06 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062330
