UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective observational study to assess the impact of COVID 19 on emergency care in Niigata city
Acronym	Impact of COVID 19 on emergency care
Scientific Title	Retrospective observational study to assess the impact of COVID 19 on emergency care in Niigata city
Scientific Title:Acronym	Impact of COVID 19 on emergency care
Region	Japan

Condition
Condition	Patients who received emergency medical care at participating medical institutions
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assess the impact of COVID 19 on emergency medical care in Niigata City
Basic objectives2	Others
Basic objectives -Others	Descriptive study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of patients at Niigata City Emergency Medical Center
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	(1) Patients at the Niigata City Emergency Medical Center (2) Patients who received emergency transportation within the Niigata City Fire Department jurisdiction (3) Dead patients in Niigata City (4) Emergency outpatients at Niigata University and Niigata City General Hospital
Key exclusion criteria	None
Target sample size	18000

Research contact person
Name of lead principal investigator	1st name Shinya Middle name Last name Fujiki
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Cardiovascular Biology and Medicine
Zip code	951-8510
Address	1-757 Asahimachidori, Chuo-ku, Niigata
TEL	025-227-2185
Email	sfujiki@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Shinya Middle name Last name Fujiki
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Cardiovascular Biology and Medicine
Zip code	951-8510
Address	1-757 Asahimachidori, Chuo-ku, Niigata
TEL	025-227-2185
Homepage URL
Email	sfujiki@med.niigata-u.ac.jp

Sponsor
Institute	Niigata university
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The ethical committees of Niigata University
Address	1-757 Asahimachidori, Chuo-ku, Niigata
Tel	025-227-2625
Email	ethics@adm.niigata-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	2021 Year 02 Month 05 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	2020 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 15 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We investigate gender, age, disease, and number of emergency transports at medical institutions

Management information
Registered date	2021 Year 02 Month 05 Day
Last modified on	2021 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049370