UMIN-CTR Clinical Trial

Basic information
Public title	Cross-sectional study of the chronic pain after mitral valve repair
Acronym	PAIN-MVP study
Scientific Title	Cross-sectional study of the chronic pain after mitral valve repair
Scientific Title:Acronym	PAIN-MVP study
Region	Japan

Condition
Condition	miitral valve regurgitation
Classification by specialty	Anesthesiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It influences the operative procedure to reveal about the chronic pain after mitral valve repair in minimally invasive cardiac surgery.
Basic objectives2	Others
Basic objectives -Others	Including the patients undergoing mitral valve repair, questionnaires were mailed about intensity and type of the pain.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of the chronic pain after mitral valve repair in MICS
Key secondary outcomes	Comparison the incidence after MICS with that after sternotomy.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)The patients undergoing mitral valve repair from January in 2014 to December in 2018 who were alive postoperative 2 months. 2) The patients who were able to answer and send the questionnaire by themselves.
Key exclusion criteria	none
Target sample size	306

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	5658565
Address	5-7-1 Fujishirodai, Suita city, Osaka
TEL	06-6833-5012
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	5658565
Address	5-7-1 Fujishirodai, Suita city, Osaka
TEL	06-6833-5012
Homepage URL
Email	k.minami@ncvc.go.jp

Sponsor
Institute	National cerebral and cardiovascular center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	5-7-1 Fujishirodai, Suita city, Osaka
Tel	06-6833-5012
Email	rec-office-ac@ncvc.go.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	2019 Year 06 Month 09 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	Terminated
Date of protocol fixation	2019 Year 02 Month 20 Day
Date of IRB	2019 Year 03 Month 14 Day
Anticipated trial start date	2019 Year 03 Month 14 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2019 Year 06 Month 04 Day
Last modified on	2021 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042116