UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034974 |
|---|---|
| Receipt number | 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 | 2022/07/04 18:09:08 |
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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
Composite cardiac events after diagnosed cardiac sarcoidosis. Cardiac events include HF admission, documented VT/VF, and death.
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.
Diagnosis of CS is according to either Japanese Circulation Society (JCS) criteria proposed in 2016 or the Heart Rhythm Society (HRS) 2014 consensus statement
Key exclusion criteria
The exclusion criterion was the refusal of a patient to be enrolled after notification that he/she is registered to this registry
Target sample size
515
Research contact person
Name of lead principal investigator
| 1st name | Takeru |
| Middle name | |
| Last name | Nabeta |
Organization
Kitasato University School of Medicine
Division name
Cardiovascular Medicine
Zip code
2520373
Address
1-15-1, Kitasato, Minami-ku, Sagamihara
TEL
0427788111
nabetake@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeru |
| Middle name | |
| Last name | Nabeta |
Organization
Kitasato University School of Medicine
Division name
Cardiovascular Medicine
Zip code
2520373
Address
1-15-1, Kitasato, Minami-ku, Sagamihara
TEL
0427788111
Homepage URL
nabetake@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
Kitasato University Medical Ethics Organization
Address
1-15-1, Kitasato, Minami-ku, Sagamihara
Tel
0427788111
rinrib@med.kitasato-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehac323/6619356?searchresul
Number of participants that the trial has enrolled
512
Results
Among 512 registered patients, 148 combined events were observed during a median follow-up of 1042 days. The 10-year estimated event rates for the primary endpoint were 48.1. On multivariable Cox regression, a history of ventricular tachycardia or fibrillation, log-transformed brain natriuretic peptide levels, left ventricular ejection fraction, and post-diagnosis radiofrequency ablation for VT independently predicted the primary endpoint.
Results date posted
| 2022 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 07 | Month | 04 | Day |
Baseline Characteristics
Cardiac sarcoidosis were diagnosed according to the recent guidelines.
mean age is 62 years. 35.7% is male.
Participant flow
Participants were included retrospectively on each institution.
Adverse events
None
Outcome measures
Referred to the above results
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 11 | Month | 22 | Day |
Last modified on
| 2022 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039878
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