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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017111
Receipt No. R000019849
Scientific Title Assessment of cardiopulmonary functional improvement after cardiac surgery using the inert gas rebreathing method
Date of disclosure of the study information 2015/08/01
Last modified on 2017/10/23

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Basic information
Public title Assessment of cardiopulmonary functional improvement after cardiac surgery using the inert gas rebreathing method
Acronym Assessment of cardiopulmonary functional improvement after cardiac surgery using the inert gas rebreathing method
Scientific Title Assessment of cardiopulmonary functional improvement after cardiac surgery using the inert gas rebreathing method
Scientific Title:Acronym Assessment of cardiopulmonary functional improvement after cardiac surgery using the inert gas rebreathing method
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is to assess what factors influence the cardiopulmonary function in response to maximum exercise after cardiac surgery.
Basic objectives2 Others
Basic objectives -Others The cardiac surgery does not always improve the patients overall cardiopulmonary function even 6 months after surgery. Not only cardiac function but also pulmonary or skeletal muscular function influences the results of the ordinarily cardiopulmonary exercise test. Although cardiac output is one of the key indices of cardiac function, it is usually difficult to measure during exercise. In this study, we plan to measure cardiac output in response to maximum exercise after cardiac surgery using the inert gas rebreathing method.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 1) Cardiac output during exercise using the inert gas rebreathing method
2) Mean mitral valve pressure gradient during exercise
3) Peak VO2 derived from cardiopulmonary exercise test
Key secondary outcomes

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients who undergo mitral valve repair for degenerative disease.
Following cardiac/pulmonary/skeletal muscular assessment were performed pre- and post (2 weeks, 3 months, 6 months, 12 months) surgery.
1) Cardiac output measurement using inert gas rebreathing method
2) Exercise stress echocardiography
3) Cardiopulmonary exercise test
4) Spirometry
5) Skeletal muscular strength, thigh/calf circumference measurement
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients who undergo mitral valve repair for degenerative disease.
2) Patients who can perform bicycle ergometer test

Key exclusion criteria 1) Patients who is in atrial fibrillation
2) Patients who has more than moderate residual mitral regurgitation
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Yaku
Organization Kyoto Prefectural University of Medicine
Division name Department of Cardiovascular surgery
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto
TEL 075-251-5752
Email yakuh@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Doi
Organization Kyoto Prefectural University of Medicine
Division name Department of Cardiovascular surgery
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto
TEL 075-251-5752
Homepage URL
Email kdoi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Department of Cardiovascular Surgery
Institute
Department

Funding Source
Organization 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
Address
Tel
Email

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 08 Month 01 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
2015 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 12 Day
Last modified on
2017 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019849

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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