UMIN-CTR Clinical Trial

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
Email	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
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	the Human Ethics Review Committee of Kumamoto University
Address	1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
Tel	81-96-373-5657
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027493