UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035530 |
|---|---|
| Receipt number | R000040480 |
| Scientific Title | 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 15:16:19 |
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Basic information
Public title
Risk stratification in Brugada syndrome: analysis of unipolar Holter electrocardiogram after Pilsicainide provocation.
Acronym
Unipolar Holter electrocardiogram after Pilsicainide provocation in Brugada syndrome.
Scientific Title
Risk stratification in Brugada syndrome: analysis of unipolar Holter electrocardiogram after Pilsicainide provocation.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masahiko Takagi |
Organization
Kansai Medical University
Division name
Department of Medicine 2
Zip code
Address
10-15 Fumizono-cho, Moriguchi, Osaka
TEL
(06)6992-1001
takagims@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Takagi |
Organization
Kansai Medical University
Division name
Department of Medicine 2
Zip code
Address
10-15 Fumizono-cho, Moriguchi, Osaka
TEL
(06)6992-1001
Homepage URL
takagims@takii.kmu.ac.jp
Sponsor or person
Institute
Department of Medicine 2 Kansai Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 10 | Month | 02 | Day |
Date of IRB
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
Other
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
Value
https://center6.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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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
