UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052836 |
|---|---|
| Receipt number | R000059673 |
| Scientific Title | Japanese multicenter registry of thyroid storm to identify prognostic factors and therapeutic targets. |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2023/11/18 10:17:09 |
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Basic information
Public title
Japanese multicenter registry of thyroid storm to identify prognostic factors and therapeutic targets.
Acronym
Japanese thyroid strom registry
Scientific Title
Japanese multicenter registry of thyroid storm to identify prognostic factors and therapeutic targets.
Scientific Title:Acronym
Japanese thyroid strom registry
Region
| Japan |
Condition
Condition
Thyroid crisis/storm
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will analyze the background, treatment, and prognosis of patients with thyroid storm from large databases to understand their actual state of medical practice.
Basic objectives2
Others
Basic objectives -Others
Hospitals involved in the treatment of thyroid storm will be selected from a database, and a secondary survey and analysis of the details of treatment and long-term prognosis will be conducted at facilities that cooperate in the study to understand the actual status of diagnosis, treatment, and prognosis of thyroid storm, and to identify prognostic factors and their therapeutic targets and strategies.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital death
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were admitted as emergency therapeutic admissions and those who underwent blood tests for thyroid functions and administered both antithyroid therapy and inorganic iodine therapy from JROAD database between 2012 and 2021.
Key exclusion criteria
Patients who were died before index hospitalization
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Yasuhide |
| Middle name | |
| Last name | Asaumi |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Cardivascular Care Unit, Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibe-shimmachi, Suita, Osaka, Japan
TEL
06-6170-1070
asaumiya@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Yasuhide |
| Middle name | |
| Last name | Asaumi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibe-shimmachi. Suita, Osaka
TEL
06-6170-1070
Homepage URL
asaumiya@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Yasuhide Asaumi
Funding Source
Organization
Self fundings
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
National Cerebral and Cardiovascular Center
Address
6-1 KIshibe-shimmachi, Suita, Osaka
Tel
06-6170-1070
rec-office-ac@ncvc.go.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
| 2023 | Year | 11 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 16 | 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
Multicenter, retrospective, and observational study
Management information
Registered date
| 2023 | Year | 11 | Month | 18 | Day |
Last modified on
| 2023 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059673
