UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023864
Receipt No. 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 2017/09/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Seiji Hokimoto
Organization Kumamoto University
Division name the Department of Cardiovascular Medicine, Graduate School of Medical Sciences
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
TEL 81-96-373-5175
Email shokimot@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Fujisue
Organization Kumamoto University
Division name the Department of Cardiovascular Medicine, Graduate School of Medical Sciences
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
TEL 81-96-373-5175
Homepage URL
Email fujisues@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

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
Address
Tel
Email

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 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
2016 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 08 Day
Last follow-up date
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
2017 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027493

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.