UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050482 |
|---|---|
| Receipt number | R000057504 |
| Scientific Title | Impact of graft velocity on saphenous vein graft disease after coronary artery bypass grafting |
| Date of disclosure of the study information | 2023/03/03 |
| Last modified on | 2023/03/03 17:50:40 |
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Basic information
Public title
Impact of graft velocity on saphenous vein graft disease after coronary artery bypass grafting
Acronym
Impact of graft velocity on saphenous vein graft disease after coronary artery bypass grafting
Scientific Title
Impact of graft velocity on saphenous vein graft disease after coronary artery bypass grafting
Scientific Title:Acronym
Impact of graft velocity on saphenous vein graft disease after coronary artery bypass grafting
Region
| Japan |
Condition
Condition
old myocardial infarction, angina pectoris, ischemic cardiomyopathy
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Saphenous vein graft (SVG) is frequently used in coronary artery bypass grafting (CABG), but its long term patency rate is lower than that of other arterial grafts due to vein graft disease (VGD). We evaluated the factors causing VGD in conventionally harvested SVG (C-SVG), and the difference of intraoperative factors between C-SVG and no-touch harvested SVG (N-SVG).
Basic objectives2
Others
Basic objectives -Others
analysis for detecting the factors contributing vein graft disease in conventional harvest SVG. analysis of the difference of intraoperative graft flow characteristics and postoperative graft diameter
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
vein graft occlusion or stenosis
Key secondary outcomes
Intraoperative assessment of graft flow, postoperative graft diameter determined by coronary computed tomography angiography, and calculated graft velocity
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
patients who underwent CABG with conventional SVG between 2010 and 2017 and who had subsequent postoperative CCTA follow-up
patients who underwent CABG with non-touch SVG between June 2019 and December 2021
Key exclusion criteria
Acute myocardial infarction
conventional harvest SVG (who did not have CT follow-uo within 3 months postoperatively, and who did not have subsequent CT follow-up)
non-touch SVG (who did not have CT follow-uo within 3 months postoperatively)
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Nakamura |
Organization
Wakayama Medical University
Division name
Cardiothoracic surgery
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama city, Wakayama prefecture, Japan
TEL
073-447-2300
m09077rn@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Nakamura |
Organization
Wakayama Medical University
Division name
Cardiothoracic surgery
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama city, Wakayama prefecture, Japan
TEL
073-447-2300
Homepage URL
m09077rn@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Clinical study support centor, Wakayama Medical University
Address
811-1, Kimiidera, Wakayama city, Wakayama prefecture, Japan
Tel
073-441-0887
crc@wakayama-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 | 03 | Month | 03 | 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
120
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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis1
Retrospective analysis of conventional harvest SVGs to detect the factors affecting VGD
Analysis2
Propensity score matched analysis of mean graft flow and graft velocity measurement between C-SVG and N-SVG
Management information
Registered date
| 2023 | Year | 03 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057504
