UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034070
Receipt No. R000037909
Scientific Title Detection of atrial fibrillation using telemetry ECG device
Date of disclosure of the study information 2018/10/15
Last modified on 2019/09/09

* 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 Detection of atrial fibrillation using telemetry ECG device
Acronym Detection of atrial fibrillation using telemetry ECG device
Scientific Title Detection of atrial fibrillation using telemetry ECG device
Scientific Title:Acronym Detection of atrial fibrillation using telemetry ECG device
Region
Japan

Condition
Condition atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate if a telemetry ECG device can detect the atrial fibrillation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The comparison between the detection of atrial fibrillation by telemetry ECG device and conventional Holter ECG.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 To attach the telemetry ECG device at the anterior part of the chest, for 12 to 24 hours.
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 Healthy subjects, and patients who visit Tokyo Medical and Dental University Medical Hospital for the treatment of atrial fibrillation.
Key exclusion criteria Subjects who are not eligible for Holter electrocardiography recording.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Sasano
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine
Zip code 113-8519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5231
Email sasano.cvm@tmd.ac.jp

Public contact
Name of contact person
1st name Tetsuo
Middle name
Last name Sasano
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine
Zip code 113-8519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5231
Homepage URL
Email sasano.cvm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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 Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel 03-5803-5096
Email syomu1.adm@tmd.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
2018 Year 10 Month 15 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 Enrolling by invitation
Date of protocol fixation
2018 Year 09 Month 19 Day
Date of IRB
2018 Year 09 Month 18 Day
Anticipated trial start date
2018 Year 09 Month 20 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 08 Day
Last modified on
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037909

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.