UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037665 |
|---|---|
| Receipt number | R000042938 |
| Scientific Title | Observational study to evaluate the usefulness of intracardiac electrocardiogram as a monitoring for right ventricular function in minimally invasive cardiac surgery |
| Date of disclosure of the study information | 2019/08/11 |
| Last modified on | 2024/08/14 09:53:55 |
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Basic information
Public title
Observational study to evaluate the usefulness of intracardiac electrocardiogram as a monitoring for right ventricular function in minimally invasive cardiac surgery
Acronym
The usefulness of intracardiac ECG as a monitoring for right ventricular function in minimally invasive cardiac surgery
Scientific Title
Observational study to evaluate the usefulness of intracardiac electrocardiogram as a monitoring for right ventricular function in minimally invasive cardiac surgery
Scientific Title:Acronym
The usefulness of intracardiac ECG as a monitoring for right ventricular function in minimally invasive cardiac surgery
Region
| Japan |
Condition
Condition
Patients scheduled for minimally invasive cardiac surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of intracardiac ECG as a monitoring for right ventricular function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative changes in QRS duration
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 scheduled for minimally invasive cardiac surgery
Key exclusion criteria
Patients with WPW syndrome or permanent cardiac pacemakers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Hori |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
545-8586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
0666452186
k.hori@omu.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Hori |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
545-8586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
0666452186
Homepage URL
k.hori@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka Metropolitan University Hospital Certified Review Board
Address
1-2-7-601 Asahimachi, Abeno-ku, Osaka 545-0051, Japan
Tel
0666453456
gr-a-knky-ethics@omu.ac.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 | 08 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2024 | 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 to evaluate the usefulness of intracardiac electrocardiogram as a monitoring for right ventricular function in minimally invasive cardiac surgery
Management information
Registered date
| 2019 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042938
