UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056190 |
|---|---|
| Receipt number | R000064212 |
| Scientific Title | A Clinical Retrospective Database of Takotsubo Cardiomyopathy after Hemorrhagic Stroke: Assessing the Radiographic and Clinical Features Associated with Clinical Outcomes |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2024/11/19 11:56:50 |
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Basic information
Public title
A Clinical Retrospective Database of Takotsubo Cardiomyopathy after Hemorrhagic Stroke: Assessing the Radiographic and Clinical Features Associated with Clinical Outcomes
Acronym
A Clinical Retrospective Database of Takotsubo Cardiomyopathy after Hemorrhagic Stroke: Assessing the Radiographic and Clinical Features Associated with Clinical Outcomes
Scientific Title
A Clinical Retrospective Database of Takotsubo Cardiomyopathy after Hemorrhagic Stroke: Assessing the Radiographic and Clinical Features Associated with Clinical Outcomes
Scientific Title:Acronym
A Clinical Retrospective Database of Takotsubo Cardiomyopathy after Hemorrhagic Stroke: Assessing the Radiographic and Clinical Features Associated with Clinical Outcomes
Region
| Japan |
Condition
Condition
Takotsubo Cardiomyopathy
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To build a database of patients diagnosed with Takotsubo cardiomyopathy and any intracranial hemorrhage, and to better elucidate upon prognostic clinical correlates and management practices. Patients treated surgically and non-surgically will be included in this database.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients are classified as good prognosis (mRS 0-3) or poor prognosis (mRS 4-6) according to the modified Rankin Scale (mRS) score at discharge. Patient background such as age, gender, and medical history, severity of illness at presentation, various laboratory findings (CT, MRI, cerebral angiography, echo, blood tests, etc.), treatment details, surgical information, surgical and medical complications, and outcome will be reviewed.
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
| 15 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with hemorrhagic stroke (subarachnoid or intracerebral hemorrhage) and takotsubo cardiomyopathy who were hospitalized and treated in our department.
Key exclusion criteria
Patients who died prior to admission or who were denied participation by opt-out
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomomichi |
| Middle name | |
| Last name | Kayahara |
Organization
Saitama Medical University International Medical Center
Division name
Department of Cerebrovascular Surgery
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
+81-42-984-4111
t_kayahara@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomomichi |
| Middle name | |
| Last name | Kayahara |
Organization
Saitama Medical University International Medical Center
Division name
Department of Cerebrovascular Surgery
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
+81-42-984-4111
Homepage URL
t_kayahara@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
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
Saitama Medical University International Medical Center
Address
1397-1 Yamane, Hidaka, Saitama, Japan
Tel
+81-42-984-4111
chikens@saitama-med.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
| 2024 | Year | 12 | Month | 31 | 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
| 2024 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient background such as age, gender, and medical history, severity of illness at presentation, various laboratory findings (CT, MRI, cerebral angiography, echo, blood tests, etc.), treatment details, surgical information, surgical and medical complications, and outcome
Management information
Registered date
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064212
