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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035530
Receipt No. R000040480
Official scientific title of the study Risk stratification in Brugada syndrome: analysis of unipolar Holter electrocardiogram after Pilsicainide provocation.
Date of disclosure of the study information 2019/01/12
Last modified on 2019/01/12

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Basic information
Official scientific title of the study Risk stratification in Brugada syndrome: analysis of unipolar Holter electrocardiogram after Pilsicainide provocation.
Title of the study (Brief title) Unipolar Holter electrocardiogram after Pilsicainide provocation in Brugada syndrome.
Region
Japan

Condition
Condition Brugada syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the prognostic value for fatal ventricular arrhythmias using unipolar Holter ECG (Fukuda Electronics Co., Ltd.: FM - 980) after pilsicainide provocation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate late potentials [LP: filtered QRS(f-QRS), duration of low-amplitude signals :LAS40 and root mean square voltage:RMS40], ST amplitude(mV), QTc interval, J amplitude and T-wave alternans (TWA) in leads V2 and V5 on unipolar Holter electrocardiogram after the plisicainide provocation.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Consecutive patients who with Brugada syndrome
Key exclusion criteria 1) Patients with bundle branch block.
2)Patients with left ventricular dysfunction and/or structural heart diseases.
3) Patients who have an invasive therapy for other disease.
4) Patients who cannot undergo Holter ECG.
5) Patients who rejected the inclusion in this study.
Target sample size 50

Research contact person
Name of lead principal investigator Masahiko Takagi
Organization Kansai Medical University
Division name Department of Medicine 2
Address 10-15 Fumizono-cho, Moriguchi, Osaka
TEL (06)6992-1001
Email takagims@takii.kmu.ac.jp

Public contact
Name of contact person Masahiko Takagi
Organization Kansai Medical University
Division name Department of Medicine 2
Address 10-15 Fumizono-cho, Moriguchi, Osaka
TEL (06)6992-1001
Homepage URL
Email takagims@takii.kmu.ac.jp

Sponsor
Institute Department of Medicine 2 Kansai Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 関西医科大学総合医療センター(大阪府)/ Kansai Medical University Medical Center

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 12 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 02 Day
Anticipated trial start date
2018 Year 10 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Prospective study.
We'll enroll the patients with Brugada-type ECG from IRB approval to Mar. 2023.
We'll perform unipolar Holter ECG after Pilsicainide provocation and identify the prognostic risk factors by evaluating late potentials, ST amplitue, dQTc interva, J wave amplitude and T-wave alternans (TWA).

Management information
Registered date
2019 Year 01 Month 12 Day
Last modified on
2019 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040480

Research Plan
Registered date File name

Research case data specifications
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Research case data
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