UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036965
Receipt number R000042116
Scientific Title Cross-sectional study of the chronic pain after mitral valve repair
Date of disclosure of the study information 2019/06/09
Last modified on 2021/06/06 16:04:03

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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 or person

Institute

National cerebral and cardiovascular center

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042116


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name