UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058254 |
|---|---|
| Receipt number | R000066589 |
| Scientific Title | Comparison of antegrade cardioplegia and retrograde cardioplegia in myocardial protection during isolated aortic valve replacement |
| Date of disclosure of the study information | 2025/06/24 |
| Last modified on | 2025/06/23 12:09:53 |
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Basic information
Public title
Comparison of antegrade cardioplegia and retrograde cardioplegia in myocardial protection during isolated aortic valve replacement
Acronym
Comparison of myocardial protection during aortic valve replacement
Scientific Title
Comparison of antegrade cardioplegia and retrograde cardioplegia in myocardial protection during isolated aortic valve replacement
Scientific Title:Acronym
ACDRCD test
Region
| Japan |
Condition
Condition
Aortic valve stenosis and regurgitation
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of antegrade cardioplegia delivery (ACD) versus retrograde cardioplegia delivery (RCD) remains controversial. This study aimed to compare the efficacy of intermittent and isothermic ACD (IIACD) with continuous and hypothermic RCD (CHRCD) in patients undergoing isolated aortic valve replacement (AVR).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the peak creatine kinase-MB (CK-MB) level in peripheral blood within one week postoperatively.
Key secondary outcomes
Secondary outcomes were echocardiographic parameters such as ejection fraction (EF), wall motion, and degree of regurgitation at the mitral and tricuspid valves. Echocardiography was performed approximately one week after surgery.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients received IIACD during AVR between April 1, 2016, and December 31, 2021.
Patients received CHRCD during AVR between January 1, 2007, and March 31, 2015.
Key exclusion criteria
Excluding criteria was emergency cases, those involving concomitant valve surgeries, coronary artery bypass grafting, aortic repair, or the use of both antegrade and retrograde cardioplegia.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | JUNJI |
| Middle name | |
| Last name | NAKAZAWA |
Organization
Sapporo Medical University of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
0608543
Address
South1, West16, Chuoku, Sapporo city, Hokkaido, Japan
TEL
0116112111
bankara02@gmail.com
Public contact
Name of contact person
| 1st name | JUNJI |
| Middle name | |
| Last name | NAKAZAWA |
Organization
Sapporo Medical University of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
0608543
Address
South1, West16, Chuoku, Sapporo city, Hokkaido, Japan
TEL
0116112111
Homepage URL
bankara02@gmail.com
Sponsor or person
Institute
Sapporo Medical University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University of Medicine
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
Sapporo Medical University Ethics Committee
Address
South1, West16, Chuoku, Sapporo city, Hokkaido, Japan
Tel
0116112111
kouhou-byouin@sapmed.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
| 2025 | Year | 06 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
165
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
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 06 | Month | 23 | Day |
Last modified on
| 2025 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066589
