UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Acronym	Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Scientific Title	Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Scientific Title:Acronym	Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Region	Japan

Condition
Condition	Coronary artery disease
Classification by specialty	Surgery in general Vascular surgery Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the association between post surgical chronic pain and culdiopulmonary bypass induced inflammation.
Basic objectives2	Others
Basic objectives -Others	To investigate the association between post surgical chronic pain and culdiopulmonary bypass induced inflammation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The difference of Numerical rating scale
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing bypass surgery for coronary artery disease
Key exclusion criteria	Stroke, porcelain aorta, creatinine>=2.0, severe hiver dysfunction, LVEF<30%, COPD, redo surgery,
Target sample size	167

Research contact person
Name of lead principal investigator	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 Kishibeshinmachi, Suita
TEL	0661701070
Email	k.minami@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 Kishibeshinmachi, Suita
TEL	0661701070
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	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National cerebral and cardiovascular center
Address	6-1 Kishibeshinmachi, Suita
Tel	0661701070
Email	k.minami@ncvc.go.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	R19031
Org. issuing International ID_1	National cerebral and cardiovascular center
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 01 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	Enrolling by invitation
Date of protocol fixation	2019 Year 06 Month 06 Day
Date of IRB	2019 Year 06 Month 06 Day
Anticipated trial start date	2019 Year 06 Month 06 Day
Last follow-up date	2021 Year 01 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Investigate the difference in NRS score between on pump CABG versus off pump CABG

Management information
Registered date	2021 Year 01 Month 10 Day
Last modified on	2021 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049047

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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