UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027217 |
|---|---|
| Receipt number | R000018284 |
| Scientific Title | Research for the Utility of 12-Lead Holer ECG and Synthesized 18-Lead Synthesized ECG |
| Date of disclosure of the study information | 2017/05/14 |
| Last modified on | 2017/05/01 21:39:17 |
* 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
Research for the Utility of 12-Lead Holer ECG and Synthesized 18-Lead Synthesized ECG
Acronym
12-Lead Holer and Synthesized 18-Lead Synthesized ECG Research
Scientific Title
Research for the Utility of 12-Lead Holer ECG and Synthesized 18-Lead Synthesized ECG
Scientific Title:Acronym
12-Lead Holer and Synthesized 18-Lead Synthesized ECG Research
Region
| Japan |
Condition
Condition
cardiac disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
clarification of the the utility of 12-lead Holter and synthesized 18-lead ECG
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Death
2. Incidence or reccurence of arrythmia
3. Major adverse cardiovascular events
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
RF catheter ablation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patinets with clinically significant arrhythmia
2. Adult patients
3. Patients capable of informed consent
Key exclusion criteria
1. Patients incapable of informed consent in writing.
2. Patients incapable of ECG recording for any reasons.
3. Patients who the study director consider incompatible.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Science and Medicine,
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba City, Chiba 260-8670
TEL
81-43-226-2340
yoshio.kobayashi@wonder.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Marehiko Ueda |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Science and Medicine
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba City, Chiba 260-8670
TEL
81-43-226-2340
Homepage URL
zta10540@nifty.com
Sponsor or person
Institute
Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon Koden Co.,ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 05 | Month | 14 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | 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
| 2017 | Year | 05 | Month | 01 | Day |
Last modified on
| 2017 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018284
