UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021321
Receipt number R000024003
Scientific Title Validation of Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.
Date of disclosure of the study information 2016/03/30
Last modified on 2020/03/09 11:59:55

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Basic information

Public title

Validation of Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.

Acronym

Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.

Scientific Title

Validation of Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.

Scientific Title:Acronym

Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.

Region

Japan


Condition

Condition

Atrial Fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the validation of arrhythmic diagnosis using wrist watch type pulse wave monitoring

Basic objectives2

Others

Basic objectives -Others

Validation of arrhythmia diagnosis

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Diagnostic rate
sensitivity, specificity

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

Diagnosis

Type of intervention

Other

Interventions/Control_1

arrhythmia diagnosis by pulse wave

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Atrial Fibrillation

Key exclusion criteria

none

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kengo
Middle name
Last name Kusano

Organization

National Cerebral and Cardiovascular Center

Division name

Cardiovascular Medicine

Zip code

564-8565

Address

6-1Kishibeshinmachi,Suita,Osaka

TEL

+81661701070

Email

kusanokengo@hotmail.com


Public contact

Name of contact person

1st name Kengo
Middle name
Last name Kusano

Organization

National Cerebral and Cardiovascular Center

Division name

Cardiovascular Medicine

Zip code

564-8565

Address

6-1Kishibeshinmachi,Suita,Osaka

TEL

+81661701070

Homepage URL


Email

kusanokengo@hotmail.com


Sponsor or person

Institute

National Cerebral and Cardiovascular Center

Institute

Department

Personal name



Funding Source

Organization

AMED

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee

Address

6-1Kishibeshinmachi,Suita,Osaka

Tel

+81661701070

Email

rec-office-ac@ncvc.go.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

2016 Year 03 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

136

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

2015 Year 04 Month 30 Day

Date of IRB

2015 Year 02 Month 23 Day

Anticipated trial start date

2015 Year 06 Month 01 Day

Last follow-up date

2020 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 03 Day

Last modified on

2020 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024003


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name