UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059450 |
|---|---|
| Receipt number | R000067990 |
| Scientific Title | Prediction of graft patency using intracoronary pressure indices in coronary bypass surgery |
| Date of disclosure of the study information | 2025/10/17 |
| Last modified on | 2025/10/17 22:05:58 |
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Basic information
Public title
Prediction of graft patency using intracoronary pressure indices in coronary bypass surgery
Acronym
Prediction of graft patency using intracoronary pressure indices in coronary bypass surgery
Scientific Title
Prediction of graft patency using intracoronary pressure indices in coronary bypass surgery
Scientific Title:Acronym
Prediction of graft patency using intracoronary pressure indices in coronary bypass surgery
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study sought to compare the predictive value of preoperative FFR and NHPR for patency of in-situ ITA-LAD using postoperative coronary computed tomography angiography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Graft patency at 1st postoperative CCTA
Key secondary outcomes
the difference of preoperative coronary assessment and intraoperative transit time flow meter
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who were performed preoperative intracoronary pressure assessment with FFR and NHPR, and postoperative graft assessment with CCTA
Key exclusion criteria
patients who did not be performed CCTA due to chronic kidney disease or other resons
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
Cardiovascular and thoracic 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
cardiovascular and thoracic 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
Nakamura Ryo
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
Wakayama Medical University
Address
811-1, Kimiidera, Wakayama city, Wakayama prefecture, Japan
Tel
073-447-2300
m09077rn@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
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 17 | 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
| 2022 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The group that developed postoperative graft hypoperfusion had significantly higher preoperative FFR/NHPR values, and NHPR was a better predictor of graft hypoperfusion than FFR.
Management information
Registered date
| 2025 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067990
