UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020052 |
|---|---|
| Receipt number | R000023160 |
| Scientific Title | Efficacy of Immunohistochemical Diagnosis with Propionibacterium Acnes-Specific Monoclonal Antibody in Patients with Cardiac Sarcoidosis (Specimens Obtained from Endomyocardial biopsy) -Multicenter Study- |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2019/06/09 21:36:59 |
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Basic information
Public title
Efficacy of Immunohistochemical Diagnosis with Propionibacterium Acnes-Specific Monoclonal Antibody in Patients with Cardiac Sarcoidosis (Specimens Obtained from Endomyocardial biopsy) -Multicenter Study-
Acronym
Usefulness of p.acnes antibody in the diagnosis of cardiac sarcoidosis (EMB)
Scientific Title
Efficacy of Immunohistochemical Diagnosis with Propionibacterium Acnes-Specific Monoclonal Antibody in Patients with Cardiac Sarcoidosis (Specimens Obtained from Endomyocardial biopsy) -Multicenter Study-
Scientific Title:Acronym
Usefulness of p.acnes antibody in the diagnosis of cardiac sarcoidosis (EMB)
Region
| Japan |
Condition
Condition
Cardiac Sarcoidosis
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence(positive rate) of specific P.acnes antibody (PAB antibody) in speciemens obtained from endomycardial biopsies (EMB) in patients with cardiac sarcoidosis (CS)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the prevalence(positive rate) of PAB antibody in speciemens obtained from endomycardial biopsies patients with CS
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
1.Specimen are stored after performing EMB
in patients.
2.Regarding using sample(specimens), Informed consent and agreement are obtained from enrolled patients.
Key exclusion criteria
1. Speciemns are not siutable for our research or assessment due to poor storage condition.
2. Patients disagree with using specimens obtaind from them in the present study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsutsui |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638
TEL
011-706-6973
htsutsui@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Sakakibara |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638
TEL
011-706-6973
Homepage URL
mike.s@ninus.ocn.ne.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine,
Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
国立循環器病研究センター、和歌山県立医科大学病院、東京医科歯科大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Retrospective case-control study
Subjects: Between January 2000 and April 2015, study subjects with some heart diseases including cardiac sarcoidosis were hospitalized in our hospital and the specimens obtained from EMB of them could be stored
In this study, we obtained the agreement of patents or patient's family during participation. If it is difficult for various reasons to directly obtain from them, we posted and published the information or disclosure statement on the board in our departments.
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023160
