UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054925 |
|---|---|
| Receipt number | R000062751 |
| Scientific Title | Efficacy and safety of emergent balloon aortic valvuloplasty as rescue therapy for cardiogenic shock due to severe aortic stenosis |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2024/07/10 15:43:47 |
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Basic information
Public title
The outcome of emergent balloon aortic valvuloplasty for cardiogenic shock due to severe aortic stenosis
Acronym
The outcome of emergent balloon aortic valvuloplasty for cardiogenic shock due to severe aortic stenosis
Scientific Title
Efficacy and safety of emergent balloon aortic valvuloplasty as rescue therapy for cardiogenic shock due to severe aortic stenosis
Scientific Title:Acronym
Efficacy and safety of emergent balloon aortic valvuloplasty as rescue therapy for cardiogenic shock due to severe aortic stenosis
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The incidence of acute decompensated heart failure (ADHF) due to severe aortic stenosis (AS) is increasing with aging of the population. Especially, the prognosis of patients with AS presenting with cardiogenic shock remains poor and the optimal initial treatment for them is still unclear.
In non-TAVI centers, emergent balloon aortic valvuloplasty (BAV) has been performed as an available option for salvage. Recent papers have reported that immediate release of aortic valve obstruction by emergent BAV could improve the prognosis; whereas a delayed BAV is considered to directly related to dire outcome.
In this study, we aimed to assess efficacy and safety of emergent BAV as rescue therapy for cardiogenic shock due to severe AS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thirty-day mortality and procedural complication rates
Key secondary outcomes
Days to withdraw from mechanical support device, the days to initial rehabilitation, and clinical frailty scale at discharge.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This multi-center retrospective study in six non-TAVI centers included patients hospitalized for cardiogenic shock due to severe AS from January 2015 to July 2022.
Key exclusion criteria
The following shock status related to other causes except for severe AS were excluded from this study: acute coronary syndrome, tamponade, stress cardiomyopathy, pulmonary embolism, myocarditis, severe aortic regurgitation, severe mitral regurgitation/stenosis, or patients with concomitant sepsis or severe bleeding.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masamichi |
| Middle name | |
| Last name | Iwasaki |
Organization
Hyogo Prefectural Awaji Medical Center
Division name
Department of Cardiology
Zip code
656-0021
Address
1-1-137 Shioya, Sumoto, Hyogo, Japan
TEL
0799-22-1200
iwa_michi1114@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Iwasaki |
Organization
Hyogo Prefectural Awaji Medical Center
Division name
Department of Cardiology
Zip code
656-0021
Address
1-1-137 Shioya, Sumoto, Hyogo, Japan
TEL
0799-22-1200
Homepage URL
iwa_michi1114@yahoo.co.jp
Sponsor or person
Institute
Hyogo Prefectural Awaji Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Prefectural Awaji Medical Center
Address
1-1-137 Shioya, Sumoto, Hyogo 656-0021, Japan
Tel
0799-22-1200
Yuri_Maegawa@pref.hyogo.lg.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
| 2024 | Year | 07 | Month | 10 | 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
25
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
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This multi-center retrospective study in six non-TAVI centers included patients hospitalized for cardiogenic shock due to severe AS from January 2015 to July 2022. Cardiogenic shock was defined as the combination of 1) administration of catecholamines, including dobutamine and milrinone, insertion of intra-aortic balloon pumping (IABP), or low cardiac index less than 2.2 L/min/m2, and 2) systemic hypoperfusion identified by the combination of several parameters including altered mental status (Glasgow Coma Scale<15), cold/clammy skin and extremities, oliguria with urine output of less than 30 ml/hr, serum lactate level higher than 2.0 mmol/L (18mg/dL), or systolic blood pressure less than 90 mmHg.
All candidates were divided into two groups. The emergent group included the patients performed BAV within 12 hours from admission, and the non-emergent group included patients performed BAV more than 12hr after from admission.
Clinical information was carefully reviewed through electronic medical records from each hospital, including baseline patient characteristics, procedural details and clinical outcomes.
Management information
Registered date
| 2024 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062751
