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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007712
Receipt No. 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

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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
Email

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
Email skanemoto-cvs@md.tsukuba.ac.jp

Sponsor
Institute Department of Cardiovascular Surgery, Faculty of Medicine, Tsukuba University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009036

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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