UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cardiac ultrasound examination in the surrounding residents (including temporary housing residents) in the afflicted area of the tsunami: a case control study
Title of the study (Brief title)	Cardiac ultrasound examination in the area affected by the tsunami
Region	Japan

Condition
Condition	Cardiovascular disease
Classification by specialty	Cardiology Laboratory medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Understanding Cardiovascular Disease in Disaster Area
Basic objectives2	Others
Basic objectives -Others	Reduction of disaster-related death
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Increase in number of positive findings of cardiac ultrasound examination in the area affected by the tsunami from 2 to 5 years after the Great East Japan Earthquake
Key secondary outcomes	Number of changes in heart failure patients in the disaster areas affected by the Tsunami from 2 to 5 years after the Great East Japan Earthquake

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Residents of Tsunami Afflicted Area
Key exclusion criteria	Those who can not obtain consent
Target sample size	1000

Research contact person
Name of lead principal investigator	Osamu Yamamura
Organization	Faculty of Medical Science, University of Fukui
Division name	Deparement of Community Medicine
Address	23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL	0776-61-3111
Email	kapi@u-fukui.ac.jp

Public contact
Name of contact person	Osamu Yamamura
Organization	Faculty of Medical Science, University of Fukui
Division name	Deparement of Community Medicine
Address	23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL	0776-61-3111
Homepage URL
Email	kapi@u-fukui.ac.jp

Sponsor
Institute	University of Fukui
Institute
Department

Funding Source
Organization	Japan Society of Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 11 Month 02 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 08 Month 08 Day
Anticipated trial start date	2012 Year 09 Month 15 Day
Last follow-up date	2015 Year 10 Month 11 Day
Date of closure to data entry	2016 Year 01 Month 31 Day
Date trial data considered complete	2016 Year 09 Month 30 Day
Date analysis concluded	2018 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	We conducted echocardiogram examination for the victims of the Great East Japan Earthquake from 2012 to 2015.

Management information
Registered date	2017 Year 11 Month 02 Day
Last modified on	2017 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034050