UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of autonomic nervous activity in patients who performed operation for cardiovascular disease in postoperative period.
Acronym	Evaluation of autonomic nervous activity in patients who performed operation for cardiovascular disease in postoperative period.
Scientific Title	Evaluation of autonomic nervous activity in patients who performed operation for cardiovascular disease in postoperative period.
Scientific Title:Acronym	Evaluation of autonomic nervous activity in patients who performed operation for cardiovascular disease in postoperative period.
Region	Japan

Condition
Condition	The patients who performed operation for cardiovascular disease
Classification by specialty	Cardiovascular surgery Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate autonomic nervous activity in patients who performed operation for cardiovascular disease in postoperative period.
Basic objectives2	Others
Basic objectives -Others	To elucidate whether postoperative autonomic nervous activity recover in patients with cardiovascular disease or not.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Temporal changes in autonomic nervous activity in postoperative period
Key secondary outcomes	To investigate whether temporal changes in autonomic nervous activity could be related to onset of postoperative atrial fibrillation or not.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	ECG data is recorded in preoperative period once in supine position for fifteen minutes. In postoperative period, its recording continues from postoperative day 1 to postoperative day 7. After that, the recording performs at two or three day intervals until the patients discharge.
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	The patients who performed operation for cardiovascular disease.
Key exclusion criteria	The patients who needs urgent hospitalization. The patients with pacemaker. The patients with atrial fibrillation in preoperative period. The patients with frequent arrhythmia such as premature atrial or ventricle contraction. The patients with dialysis. The patients with ventricular assist device. The patients with dementia. The patients that decision making is impossible.
Target sample size	120

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	Department of cardiovascular surgery
Zip code	981-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
TEL	02271717222
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	Department of cardiovascular surgery
Zip code	981-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
TEL	02271717222
Homepage URL
Email	konosuke.s@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	the 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	Tohoku University School of Medicine
Address	2-1, Seiryo-machi, Aoba-ku, Sendai
Tel	0227284105
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	2015 Year 11 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	2015 Year 11 Month 08 Day
Date of IRB	2015 Year 10 Month 27 Day
Anticipated trial start date	2015 Year 11 Month 09 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 05 Day
Last modified on	2019 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022693