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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041731
Receipt No. 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

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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
Email 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
Email konosuke.s@med.tohoku.ac.jp

Sponsor
Institute Tohoku university graduate school of medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047632

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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