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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036850
Receipt No. R000041980
Scientific Title Impact of right ventricular infarction on circulation in patients with STEMI
Date of disclosure of the study information 2019/05/25
Last modified on 2019/05/25

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Basic information
Public title Impact of right ventricular infarction on circulation in patients with STEMI
Acronym PREVISE
Scientific Title Impact of right ventricular infarction on circulation in patients with STEMI
Scientific Title:Acronym PREVISE
Region
Japan

Condition
Condition ST-segment elevation myocardial infarction
Classification by specialty
Cardiology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Frequency of right ventricular infarction in STEMI
Frequency of shock with right ventricular infarction
Identification of risk factor of right ventricular infarction and shock with right ventricular infarction
Research on prognosis of right ventricular infarction and shock with right ventricular infarction
Basic objectives2 Others
Basic objectives -Others Research on frequency and prognosis
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Right ventricular infarction at arrival and admission to ICU
Shock in hospitalization
Survival at discharge
Key secondary outcomes Identification of right ventricular infarction and shock with right ventricular infarction

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 STEMI
Key exclusion criteria Out-of-hospital cardiac arrest
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tomoaki
Middle name
Last name Natsukawa
Organization Yodogawa Christian Hospital
Division name Department of emergency and intensive care
Zip code 533-0024
Address 1-7-50, Kunijima, Higashiyodogawaku, Osaka-city
TEL 06-6322-2250
Email respect_for_each@yahoo.co.jp

Public contact
Name of contact person
1st name Tomoaki
Middle name
Last name Natsukawa
Organization Yodogawa Christian Hospital
Division name Department of emergency and intensive care
Zip code 533-0024
Address 1-7-50, Kunijima, Higashiyodogawaku, Osaka-city
TEL 06-6322-2250
Homepage URL
Email respect_for_each@yahoo.co.jp

Sponsor
Institute Yodogawa Christian Hospital
Department of emergency and intensive care
Institute
Department

Funding Source
Organization Nothing
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Yodogawa Christian Hospital
Address 1-7-50, Kunijima, Higashiyodogawaku, Osaka-city
Tel 06-6322-2250
Email respect_for_each@yahoo.co.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
2019 Year 05 Month 25 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 Enrolling by invitation
Date of protocol fixation
2019 Year 02 Month 01 Day
Date of IRB
2019 Year 04 Month 06 Day
Anticipated trial start date
2019 Year 04 Month 06 Day
Last follow-up date
2024 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Department of cardiology, Yodogawa Christian Hospital

Management information
Registered date
2019 Year 05 Month 25 Day
Last modified on
2019 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041980

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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