UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026967 |
|---|---|
| Receipt number | 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 18:40:48 |
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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
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
asugiura@chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030925
