UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023121 |
|---|---|
| Receipt number | 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 21:56:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
vdm@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Department of Cardiovascular Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026647
