UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041731 |
|---|---|
| Receipt number | R000047632 |
| Scientific Title | Relationship between preoperative cardiac autonomic nervous activity and occurrence of postoperative atrial fibrillation |
| Date of disclosure of the study information | 2020/09/10 |
| Last modified on | 2020/09/08 17:08:03 |
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Basic information
Public title
Relationship between preoperative cardiac autonomic nervous activity and occurrence of postoperative atrial fibrillation
Acronym
Relationship between preoperative cardiac autonomic nervous activity and occurrence of postoperative atrial fibrillation
Scientific Title
Relationship between preoperative cardiac autonomic nervous activity and occurrence of postoperative atrial fibrillation
Scientific Title:Acronym
HRV and POAF
Region
| Japan |
Condition
Condition
Cardiovascular diseases
Classification by specialty
| Cardiovascular surgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between preoperative autonomic nervous activity on the sinus node and postoperative atrial fibrillation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preoperative autonomic nervous activity and the ratio of postoperative atrial fibrillation
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 who underwent cardiovascular surgery for valvular, ischemic heart and aortic diseases
Key exclusion criteria
History of atrial fibrillation
Frequent preoperative arrhythmia
Dialysis
Pacemaker
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Konosuke |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku university graduate school of medicine
Division name
Division of cardiovascular surgery and development of oncology nursing
Zip code
981-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7222
konosuke.s@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Konosuke |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku university graduate school of medicine
Division name
Division of cardiovascular surgery and development of oncology nursing
Zip code
981-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7222
Homepage URL
konosuke.s@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
KAKEN
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku university graduate school of medicine
Sendai kousei hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Tohoku university graduate school of medicine
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-728-4105
med-kenkyo@grp.tohoku.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
| 2020 | Year | 09 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2020 | Year | 09 | Month | 08 | Day |
Last modified on
| 2020 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047632
