UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050133 |
|---|---|
| Receipt number | R000057116 |
| Scientific Title | Effects of nitric oxide inhalation therapy in the percutaneous ventricular assist device (Impella). |
| Date of disclosure of the study information | 2023/01/30 |
| Last modified on | 2023/07/27 15:13:37 |
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Basic information
Public title
Effects of nitric oxide inhalation therapy in the percutaneous ventricular assist device (Impella).
Acronym
Effects of nitric oxide inhalation therapy in the percutaneous ventricular assist device (Impella).
Scientific Title
Effects of nitric oxide inhalation therapy in the percutaneous ventricular assist device (Impella).
Scientific Title:Acronym
Effects of nitric oxide inhalation therapy in the percutaneous ventricular assist device (Impella).
Region
| Japan |
Condition
Condition
Consecutive cases of cardiogenic shock with the use of Impella.
Classification by specialty
| Cardiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Impella device is a novel technology utilized in treating cardiogenic shock, as it is the sole method capable of transcatheter-reducing left ventricular end-diastolic pressure in Japan. In contrast, Japan only approves the use of left ventricular assist devices, resulting in patients with impaired right heart function often receiving treatment with extracorporeal membrane oxygenation, which can lead to a higher incidence of hemorrhagic complications and elevated mortality rates. Inhalation therapy with nitric oxide, however, has been established as an effective treatment for post-cardiovascular surgical hypo-anemia and can significantly decrease pulmonary arterial vascular resistance, thereby reducing right ventricular afterload. Despite the good hemodynamic effect of combination therapy with Impella and nitric oxide inhalation, their combined effect has yet to be demonstrated. Thus, the present study aims to investigate the utilization of combined nitric oxide inhalation therapy in conjunction with Impella.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-day survival
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive cases of cardiogenic shock using Impella during hospitalisation at Iwate Medical University Hospital in the last four years from 8 August 2018 to 31 March 2022.
Key exclusion criteria
Under 20 years of age
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Nasu |
Organization
Iwate Medical University
Division name
Division of Cardiology, Department of Internal Medicine. Division of Biomedical Information Analysis, Institute for Biomedical Sciences.
Zip code
028-3695
Address
2-1-1 Idaidori,Yahaba-cho,Shiwa-gun,Iwate prefecture, Japan
TEL
+81-019-613-7111
tnasu@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Nasu |
Organization
Iwate Medical University
Division name
Division of Cardiology, Department of Internal Medicine. Division of Biomedical Information Analysis
Zip code
028-3695
Address
2-1-1 Idaidori,Yahaba-cho,Shiwa-gun,Iwate prefecture, Japan
TEL
+81-019-613-7111
Homepage URL
tnasu@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
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 +81-019-613-711
Tel
+81-019-613-7111
tnasu@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
| 2023 | Year | 01 | Month | 30 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 27 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 23 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 15 | Day |
Other
Other related information
Conducting observational studies
To test the efficacy of Impella and nitric oxide inhalation combination therapy
Management information
Registered date
| 2023 | Year | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057116
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