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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034974
Receipt No. R000039878
Scientific Title Illustration of the Management and Prognosis of Japanese Patients with Cardiac Sarcoidosis
Date of disclosure of the study information 2018/11/25
Last modified on 2018/11/22

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Basic information
Public title Illustration of the Management and Prognosis of Japanese Patients with Cardiac Sarcoidosis
Acronym ILLUMINATE-CS
Scientific Title Illustration of the Management and Prognosis of Japanese Patients with Cardiac Sarcoidosis
Scientific Title:Acronym ILLUMINATE-CS
Region
Japan

Condition
Condition Cardiac Sarcoidosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical course, effect of conventional therapy, and prognosis in patients with cardiac sarcoidosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of cardiac events from diagnosed cardiac sarcoidosis
Key secondary outcomes 1. Change in cardiac function after steroid therapy
2. Resolution of atrioventricular block after steroid therapy
3. Change in inflammatory activity by imaging modality after steroid therapy
4. Efficacy of catheter ablation to ventricular tachycardia

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with cardiac sarcoidosis from January 1st, 2001 to December 31st, 2017.
Key exclusion criteria 1. Patients in which there was not enough clinical data for analysis.
2. Patients who were judged as unsuitable for the study by the investigator for other reasons.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeru Nabeta
Organization Kitasato University School of Medicine
Division name Cardiovascular Medicine
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara
TEL 0427788111
Email nabetake@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeru Nabeta
Organization Kitasato University School of Medicine
Division name Cardiovascular Medicine
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara
TEL 0427788111
Homepage URL
Email nabetake@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato 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)

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
2018 Year 11 Month 25 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 11 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 11 Month 22 Day
Last modified on
2018 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039878

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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