UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047999
Receipt No. R000054714
Scientific Title Multicentre retrospective registry trial of the efficacy and safety of fulminant myocarditis with IMPELLA
Date of disclosure of the study information 2022/06/15
Last modified on 2022/06/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multicentre retrospective registry trial of the efficacy and safety of fulminant myocarditis with IMPELLA
Acronym Multicentre retrospective registry trial of the efficacy and safety of fulminant myocarditis with IMPELLA
Scientific Title Multicentre retrospective registry trial of the efficacy and safety of fulminant myocarditis with IMPELLA
Scientific Title:Acronym Multicentre retrospective registry trial of the efficacy and safety of fulminant myocarditis with IMPELLA
Region
Japan

Condition
Condition fulminant myocarditis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety in fulminant myocarditis with or without IMPELLA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes - All-cause mortality (30-day mortality), cardiac death
Key secondary outcomes - Rate of MCS (mechanical circulatory support; IABP, ECMO, IMPELLA, left ventricular assist heart)
- Stroke
- Complications (major haemorrhage, peripheral haemostasis, sepsis, haemolysis)
- Survival, length of hospital admission
- Date and time of onset
- On admission Vital signs, presence of arrhythmia
- Admission blood samples (Hb, Ht, eGFR(cre), AST, T. Til, Peak CK/CK-MB), arterial blood gas analysis results
- Swan-Ganz catheter findings
- Echocardiographic findings
- Results of myocardial biopsy
- Presence of assisted circulation and timing of its induction (time from shock or admission to assisted circulation)

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
16 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Definition of acute myocarditis: cases with elevated serum troponin or serum CK-MB levels in which acute myocardial infarction is ruled out. Description of fulminant myocarditis: cases of acute myocarditis requiring catecholamines or an assistive circulatory device (IABP, PCPS, IMPELLA, assisted artificial heart). Pathological findings are not necessary.
Key exclusion criteria Acute coronary syndromes, under 16 years of age, cases with evident takotsubo cardiomyopathy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Morino
Organization Iwate Medical University
Division name Division of Cardiology, Department of Internal Medicine.
Zip code 0283695
Address 2-1-1 Idaidori,Yahaba-cho,Shiwa-gun,Iwate prefecture
TEL +81-019-613-7111
Email ymorino@iwate-med.ac.jp

Public contact
Name of contact person
1st name Masaru
Middle name
Last name Ishida
Organization Iwate Medical University
Division name Division of Cardiology, Department of Internal Medicine.
Zip code 0283695
Address 2-1-1 Idaidori,Yahaba-cho,Shiwa-gun,Iwate prefecture
TEL +81-019-613-7111
Homepage URL
Email maishida@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Division of Cardiology, Department of Internal Medicine.
Course Research Funds
Institute
Department

Funding Source
Organization Iwate Medical University
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 Iwate Medical University
Address 2-1-1 Idaidori,Yahaba-cho,Shiwa-gun,Iwate prefecture
Tel +81-019-613-7111
Email maishida@iwate-med.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
2022 Year 06 Month 15 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
2022 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2022 Year 06 Month 30 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicentre retrospective observational study

Management information
Registered date
2022 Year 06 Month 09 Day
Last modified on
2022 Year 06 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054714

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.