UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047623 |
|---|---|
| Receipt number | R000054304 |
| Scientific Title | Off-pump Versus On-pump Coronary Artery Bypass Grafting in Patients with an end-stage renal disease requiring maintenance dialysis |
| Date of disclosure of the study information | 2022/04/30 |
| Last modified on | 2023/10/30 10:10:33 |
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Basic information
Public title
Evaluation of coronary artery bypass surgery in patients with an end-stage renal disease requiring maintenance dialysis
Acronym
Evaluation of coronary artery bypass surgery in patients with dialysis
Scientific Title
Off-pump Versus On-pump Coronary Artery Bypass Grafting in Patients with an end-stage renal disease requiring maintenance dialysis
Scientific Title:Acronym
Off-pump Versus On-pump Coronary Artery Bypass Grafting in Patients with dialysis
Region
| Japan |
Condition
Condition
Angina pectoris, myocardial infarction
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compared the perioperative and mid-term results between off-pump coronary artery bypass grafting (CABG) and on-pump CABG in ESRD patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
All causes of death
Key secondary outcomes
major cardiac adverse events
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
Dialysis patients underwent isolated coronary artery bypass grafting.
Key exclusion criteria
We excluded cases that underwent CABG with concomitant surgery.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | akihito |
| Middle name | |
| Last name | matsushita |
Organization
Seikeikai Chiba Medical Center
Division name
Department of Cardiovascular Surgery
Zip code
2600842
Address
1-7-1, minami-cho, chiba
TEL
043-261-5111
matsushita@seikeikai-cmc.jp
Public contact
Name of contact person
| 1st name | akihito |
| Middle name | |
| Last name | matsushita |
Organization
Seikeikai Chiba Medical Center
Division name
Department of Cardiovascular Surgery
Zip code
2600842
Address
1-7-1, minami-cho, chiba
TEL
043-261-5111
Homepage URL
matsushita@seikeikai-cmc.jp
Sponsor or person
Institute
Department of Cardiovascular Surgery, Seikeikai Chiba Medical Center, Japan
Institute
Department
Personal name
Funding Source
Organization
No funding source
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
Seikeikai Chiba Medical Center
Address
1-7-1, minami-cho,chuo-ku,chiba
Tel
043-261-5111
matsushita@seikeikai-cmc.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
千葉メディカルセンター（千葉）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Preparation
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
84
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
all-causes of death
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2021 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 30 | Day |
Other
Other related information
In ESRD patients, we compared the perioperative and mid-term results between off-pump coronary artery bypass grafting (CABG) and on-pump CABG.
The number of cases in the setting was small and biased, and useful results could not be shown.
Management information
Registered date
| 2022 | Year | 04 | Month | 28 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054304
