UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053948 |
|---|---|
| Receipt number | R000061499 |
| Scientific Title | Illustration of the Management and Prognosis of Japanese Patients with Cardiac Sarcoidosis by Multimodality Imaging and Genetic Analysis |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/04/08 10:57:07 |
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Basic information
Public title
Illustration of the Management and Prognosis of Japanese Patients with Cardiac Sarcoidosis by Multimodality Imaging and Genetic Analysis
Acronym
ILLUMINATE-CS Imaging
Scientific Title
Illustration of the Management and Prognosis of Japanese Patients with Cardiac Sarcoidosis by Multimodality Imaging and Genetic Analysis
Scientific Title:Acronym
ILLUMINATE-CS Imaging
Region
| Japan |
Condition
Condition
Cardiac Sarcoidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to evaluate the association between cardiovascular magnetic resonance imaging and positron emission tomography findings, genetic findings, and clinical course 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
Composite of all-cause death, hospitalization for heart failure, and documented fatal ventricular arrhythmia events (VT/VF).
Key secondary outcomes
1. All-cause death
2. Sustained VT, VF, or appropriate ICD/CRT-D therapy
3. Non-sustained VT or appropriate ICD/CRT-D therapy
4. Hospitalization for Heart failure
5. Advanced atrioventricular block, complete atrioventricular block
6. Cardiac devices implantation (pacemaker, ICD, CRT)
7. Catheter ablation
8. Immunosuppressant therapy
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients newly diagnosed as cardiac sarcoidosis from January 1st, 2001 to December 31st, 2017.
2. Diagnosis of cardiac sarcoidosis is according to either Japanese Circulation Society (JCS) criteria proposed in 2016 or the Heart Rhythm Society (HRS) 2014 consensus statement modified at the J Am Coll Cardiol 2016 (Birnie DH, et al. J Am Coll Cardiol 2016;68:411-21)
3. Patients who provided informed consent are eligible for genetic analysis.
Key exclusion criteria
1. Patients without sufficient information for this study
2. Patients who contact persons judge as ineligible for this study
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Matsue |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
yuya8950@gmail.com
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Aikawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
tadao.aikawa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-5672
hongo-rinri@juntendo.ac.jp
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
順天堂大学医学部附属順天堂医院（東京都）、亀田総合病院（千葉県）、北里大学病院（神奈川県）、大阪大学医学部附属病院（大阪府）、神戸市立医療センター中央市民病院（兵庫県）、日本大学医学部附属板橋病院（東京都）、名古屋大学医学部附属病院（愛知県）、北里大学北里研究所病院（東京都）、筑波大学附属病院（茨城県）、聖マリアンナ医科大学病院（神奈川県）、高知大学医学部附属病院（高知県）、昭和大学横浜市北部病院（神奈川県）、浜松医科大学医学部附属病院（静岡県）、神戸大学医学部附属病院（兵庫県）、広島大学病院（広島県）、天理よろづ相談所病院（奈良県）、奈良県立医科大学附属病院（奈良県）、琉球大学病院（沖縄県）、埼玉医科大学国際医療センター（埼玉県）、武蔵野赤十字病院（東京都）、東京大学医学部附属病院（東京都）、国立循環器病研究センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061499
