UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007712 |
|---|---|
| Receipt number | R000009036 |
| Scientific Title | Observational study on usefullnes of high frequency QRS potentials during perioperative periods in pediatric cardiac surgery |
| Date of disclosure of the study information | 2012/04/10 |
| Last modified on | 2012/04/10 09:25:38 |
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Basic information
Public title
Observational study on usefullnes of high frequency QRS potentials during perioperative periods in pediatric cardiac surgery
Acronym
High frequency QRS potentials during pediatric cardiac surgery.
Scientific Title
Observational study on usefullnes of high frequency QRS potentials during perioperative periods in pediatric cardiac surgery
Scientific Title:Acronym
High frequency QRS potentials during pediatric cardiac surgery.
Region
| Japan |
Condition
Condition
Congenital heart disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to observe the changes in high-frequency QRS potentials (RMS potentials) during the pediatric open heart surgery and compare the changes in RMS potentials with biomarker for myocardial damadge (CK-MB), and to evaluate the usefullness of RMS potentias as an indicator of myocardial function during perioperative period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Compare the RMS potentials with biomarker for myocardial damadge (CK-MB), and evaluate the correlation between CK-MB and RMS potentials.
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
| 1 | months-old | < |
Age-upper limit
| 216 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with congenital heart disease who are scheduled to undergoe cardiac surgery with cardiopulmonary bypass.
Key exclusion criteria
Neonate, patients with unstable conditions. and patientes who did not agree to participate in this study are excluded
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Kanemoto |
Organization
University of Tsukuba
Division name
Department of Cardiovascular Surgery, Faculty of Medicine
Zip code
Address
1-1-1 Tennnodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3210
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Kanemoto |
Organization
University of Tsukuba
Division name
Department of Cardiovascular Surgery, Faculty of Medicine
Zip code
Address
TEL
Homepage URL
skanemoto-cvs@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Surgery, Faculty of Medicine, Tsukuba University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2012 | Year | 04 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
We are in process of recruintg participants
Management information
Registered date
| 2012 | Year | 04 | Month | 10 | Day |
Last modified on
| 2012 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009036
