UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022724
Receipt number R000025940
Scientific Title A pilot study of detection of asymptomatic atrial fibrillation using wristwatch-type sphygmograph among patients with sinus rhythm and high CHADS2 score (CVI ARO 3c study)
Date of disclosure of the study information 2016/06/13
Last modified on 2020/06/17 11:12:04

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Basic information

Public title

A pilot study of detection of asymptomatic atrial fibrillation using wristwatch-type sphygmograph among patients with sinus rhythm and high CHADS2 score (CVI ARO 3c study)

Acronym

CVI ARO 3c study

Scientific Title

A pilot study of detection of asymptomatic atrial fibrillation using wristwatch-type sphygmograph among patients with sinus rhythm and high CHADS2 score (CVI ARO 3c study)

Scientific Title:Acronym

CVI ARO 3c study

Region

Japan


Condition

Condition

Patients with sinus rhythm and high CHADS2 score

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To screen atrial fibrillation using a wristwatch-type sphygmograph among patients with sinus rhythm and CHADS2 >= 2 points.

Basic objectives2

Others

Basic objectives -Others

Evaluation of usefulness of sphygmographic devise

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Detection of incidence of atrial fibrillation

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with sinus rhythm and CHADS2 score >= 2 points, and without a symptom of palpitation.

Key exclusion criteria

(1) Patients who already received a diagnosis of tachyarrhythmia including atrial fibrillation
(2) Patients who already received antiarrhythmic drugs (type I - IV antiarrhythmic drugs, and digitalis)

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Shinya
Middle name
Last name Suzuki

Organization

The Cardiovascular Institute

Division name

Department of cardiovascular medicine

Zip code

106-0031

Address

3-2-19 Nishiazabu, Minato-Ku, Tokyo. ZIP: 106-0031

TEL

+81-3-3408-2151

Email

sinsuz-tky@umin.net


Public contact

Name of contact person

1st name Kazumi
Middle name
Last name Matsuda

Organization

Cardiovascular Institute Academic Research Organization (CVI ARO)

Division name

Head office

Zip code

106-0031

Address

3-2-19 Nishiazabu, Minato-Ku, Tokyo

TEL

+81-3-3408-2151

Homepage URL


Email

matsuda@cvi.or.jp


Sponsor or person

Institute

The Cardiovascular Institute Academic Organization (CVI ARO)

Institute

Department

Personal name



Funding Source

Organization

Seiko Epson Corporation

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

Ethical Committee of The Cardiovascular Institute

Address

Nishi-azabu 3-2-19, Minato-ku, Tokyo

Tel

03-3408-2151

Email

matsuda@cvi.or.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

心臓血管研究所付属病院(The Cardiovascular Institute)


Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 13 Day


Related information

URL releasing protocol

https://www.cvi.or.jp/kenkyujo/cviaro.html#link01

Publication of results

Published


Result

URL related to results and publications

https://www.cvi.or.jp/kenkyujo/cviaro.html#link01

Number of participants that the trial has enrolled

56

Results

1) Patient-basis, 8 AF out of 56 patients (16.7%).
2) Time-interval-basis, AF was found in 69 time intervals out of 6807 time intervals (1.01%).

Results date posted

2020 Year 06 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Asymptomatic non-AF patients with CHADS2 >=2

Participant flow

Registering out of outpatients in the Cardiovascular Institute

Adverse events

None.

Outcome measures

Diagnosis of AF using a pulse monitoring device.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 09 Month 19 Day

Date of IRB

2015 Year 04 Month 23 Day

Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 09 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Recruitment and analysis were completed.


Management information

Registered date

2016 Year 06 Month 13 Day

Last modified on

2020 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025940


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name