UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017111 |
|---|---|
| Receipt number | 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 20:32:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kdoi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Department of Cardiovascular Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019849
