UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047999 |
|---|---|
| Receipt number | 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 | 2023/06/10 02:58:33 |
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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
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
maishida@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Division of Cardiology, Department of Internal Medicine.
Course Research Funds
Institute
Department
Personal name
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
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
0
Results
None due to discontinuation of the study.
Results date posted
| 2023 | Year | 06 | Month | 10 | Day |
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
Terminated
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 31 | 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
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054714
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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