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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023121
Receipt No. R000026647
Scientific Title Examination for the role of humoral factors in patients with Brugada Syndrome
Date of disclosure of the study information 2016/10/01
Last modified on 2016/07/11

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Basic information
Public title Examination for the role of humoral factors in patients with Brugada Syndrome
Acronym Examination for the role of humoral factors in patients with Brugada Syndrome
Scientific Title Examination for the role of humoral factors in patients with Brugada Syndrome
Scientific Title:Acronym Examination for the role of humoral factors in patients with Brugada Syndrome
Region
Japan

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

Objectives
Narrative objectives1 Investigation for the relationship of humoral factors and electrophysiological changes.
Basic objectives2 Others
Basic objectives -Others We examine the change of humoral factors, especially such as lipid and cytokines, and the changes of electrocardiogram, for the purpose of investigate the relationship of humoral factors and electrophysiological changes.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of humoral factors and associated electrocardiogram changes
Key secondary outcomes Laboratory data;
Inflammatory marker, such as
White Blood Cells, CRP,
Inflammatory cytokines,
Serum lipid

Electrocardiogram change

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Food
Interventions/Control_1 Patients arm; Blood sampling and electrocardiogram of patients with Brugada syndrome is examined after intake of a certain amount of meal. Examinations are done before intake of meal and after 1 hour, 2 hour and 3 hour from intake it.
Interventions/Control_2 Control arm; Blood sampling and electrocardiogram of patients with healthy controls examined after intake of a certain amount of meal. Examinations are done before intake of meal and after 1 hour, 2 hour and 3 hour from intake it.
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 Patients with Brugada syndrome definitely diagnosed according to guideline of Japanese Circulation Society, and healthy controls, who have no particular past history and have similar age and gender with patients with Brugada syndrome.
Key exclusion criteria Febrile patients,
and patients with intake of Tacrolimus.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Nakano
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 seiryo-cho, aoba-ku
TEL 0227177153
Email vdm@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Nakano
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 seiryo-cho, aoba-ku
TEL 0227177153
Homepage URL
Email vdm@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization Self-funding
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
Address
Tel
Email

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 10 Month 01 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
2016 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 11 Day
Last modified on
2016 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026647

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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