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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027217
Receipt No. 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

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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
Email 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
Email zta10540@nifty.com

Sponsor
Institute Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018284

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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