UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023864 |
|---|---|
| Receipt number | R000027493 |
| Scientific Title | The Investigation of the Incidence and the Prognosis of Acute Cardiovascular and Cerebral Disease in Kumamoto Earthquakes 2016 |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2022/03/06 10:13:43 |
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Basic information
Public title
The Investigation of the Incidence and the Prognosis of Acute Cardiovascular and Cerebral Disease in Kumamoto Earthquakes 2016
Acronym
The Investigation of the Incidence and the Prognosis of Acute Cardiovascular and Cerebral Disease in Kumamoto Earthquakes 2016
Scientific Title
The Investigation of the Incidence and the Prognosis of Acute Cardiovascular and Cerebral Disease in Kumamoto Earthquakes 2016
Scientific Title:Acronym
The Investigation of the Incidence and the Prognosis of Acute Cardiovascular and Cerebral Disease in Kumamoto Earthquakes 2016
Region
| Japan |
Condition
Condition
Acute onset cases of cerebral and cardiovascular diseases [sudden cardiac death, pulmonary thromboembolism/deep venous thrombosis, heart failure, Takotsubo cardiomyopathy, stroke, aortic dissection, arrhythmia (ventricular fibrillation, ventricular tachycardia, atrial fibrillation, supraventricular tachycardia, sick sinus syndrome, and high-grade atrioventricular blocks), seizure, epilepsy, and hypertension] require hospitalization and death from these diseases after Kumamoto earthquakes 2016.
Classification by specialty
| Medicine in general | Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the number of acute onset cases of cerebral and cardiovascular diseases require hospitalization and death from these diseases after Kumamoto earthquakes 2016, and reveal the prognosis of these diseases. We also correct and grasp the information of each patient from Kumamoto University hospital and 20 related institutions. We use the result in the prevention and the improvement prognosis of cerebral and cardiovascular diseases associated with disasters.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age, sex, disease name, basal disease, date and time of onset, time to admission from onset, severity of disease, detail of treatment, date of discharge, and prognosis. Observation period is 5 years prospectively. We also retrospectively investigate the number of cases of cerebral and cardiovascular diseases up to 3 years to compared differences of pre/post Kumamoto earthquakes 2016.
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
Acute onset cases of cerebral and cardiovascular diseases [sudden cardiac death, pulmonary thromboembolism/deep venous thrombosis, heart failure, Takotsubo cardiomyopathy, stroke, aortic dissection, arrhythmia (ventricular fibrillation, ventricular tachycardia, atrial fibrillation, supraventricular tachycardia, sick sinus syndrome, and high-grade atrioventricular blocks), seizure, epilepsy, and hypertension] require hospitalization and death from these diseases after Kumamoto earthquakes 2016.
Key exclusion criteria
none
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Hokimoto |
Organization
Kumamoto University
Division name
the Department of Cardiovascular Medicine, Graduate School of Medical Sciences
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
TEL
81-96-373-5175
shokimot@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Fujisue |
Organization
Kumamoto University
Division name
the Department of Cardiovascular Medicine, Graduate School of Medical Sciences
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
TEL
81-96-373-5175
Homepage URL
fujisues@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Human Ethics Review Committee of Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
Tel
81-96-373-5657
ski-shien@jimu.kumamoto-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
| 2016 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/83/6/83_CJ-18-1369/_article
Number of participants that the trial has enrolled
1673
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation and epidemiological study
Management information
Registered date
| 2016 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027493
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
