UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036850
Receipt number 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 11:39:35

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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 or person

Institute

Yodogawa Christian Hospital
Department of emergency and intensive care

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041980