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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026967
Receipt No. R000030925
Scientific Title Early Predictor of Weaning Failure from Veno-Arterial Extracorporeal Membrane Oxygenation in Patients with Acute Myocardial Infarction-Induced Cardiac Arrest
Date of disclosure of the study information 2017/04/12
Last modified on 2017/04/12

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Basic information
Public title Early Predictor of Weaning Failure from Veno-Arterial Extracorporeal Membrane Oxygenation in Patients with Acute Myocardial Infarction-Induced Cardiac Arrest
Acronym Cardiac reversibility on ECMO after AMI
Scientific Title Early Predictor of Weaning Failure from Veno-Arterial Extracorporeal Membrane Oxygenation in Patients with Acute Myocardial Infarction-Induced Cardiac Arrest
Scientific Title:Acronym Cardiac reversibility on ECMO after AMI
Region
Japan

Condition
Condition Cardiac arrest
Acute myocardial infarction
Classification by specialty
Cardiology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to determine the specific early predictors of weaning failure from VA-ECMO due to insufficient recovery of cardiac or brain function. The ability to predict myocardial recovery in the early phase would allow more efficient decision-making regarding the application of VAD or termination of therapy in patients who are not suitable for VAD because of social or economic constraints.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Weaning failure from VA-ECMO
Key secondary outcomes 30 day mortality
Inhospital mortality
Baseline characteristics
Laboratory findings
Angiographic data
LV ejection fraction
Vasoactive inotropic score

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients were included if they were aged 18 or more than 18 years old, diagnosed acute myocardial infarction complicated by cardiac arrest, received veno arterial extracorporeal oxygenation for cardiac arrest, and received percutaneous coronary intervention to occluded artery for acute myocardial infarction.
Key exclusion criteria Patients were excluded if they received emergent cardiac surgery after percutaneous coronary intervention, were decannulated within 24 h after initiating veno arterial extracorporeal oxygenation, or died within 24 h.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Kobayashi
Organization Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-8-1, inohana, Chiba-city, Chiba-Pref, Japan
TEL 043-222-7171
Email yuiryosuke@msn.com

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Sugiura
Organization Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-8-1, inohana, Chiba-city, Chiba-Pref, Japan
TEL 043-222-7171
Homepage URL
Email asugiura@chiba-u.jp

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Grant from SENSHIN Medical Research Foundation by Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 12 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 Completed
Date of protocol fixation
2016 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information case control analysis
Patient selection was described in the study design form.
Primary endpoint is the weaning failure from veno arterial extracorporeal membrane oxygenation.
We determine the specific predictor of weaning failure by using logistic regression analysis.

Management information
Registered date
2017 Year 04 Month 12 Day
Last modified on
2017 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030925

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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