UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045274 |
|---|---|
| Receipt number | R000051714 |
| Scientific Title | Coronary artery bypass grafting in the evaluation of coronary artery volume |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/08/26 16:18:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Coronary artery bypass grafting in the evaluation of coronary artery volume
Acronym
Coronary artery bypass grafting in the evaluation of coronary artery volume
Scientific Title
Coronary artery bypass grafting in the evaluation of coronary artery volume
Scientific Title:Acronym
Coronary artery bypass grafting in the evaluation of coronary artery volume
Region
| Japan |
Condition
Condition
angina pectoris
Classification by specialty
| Cardiology | Surgery in general | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will use computer analysis to examine the hemodynamic behavior of left internal thoracic artery (LITA) blood flow and right internal thoracic artery (RITA) blood flow anastomosed to the left coronary artery anterior descending branch (LAD) for virtual coronary stenosis lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Preoperative coronary computed tomography (CT) will be performed on patients who are considering coronary artery bypass grafting to evaluate the hydrodynamics of the coronary lesion. The same evaluation will be performed after the patient's coronary artery bypass surgery to determine how the flow pattern has changed. The primary outcome is the completion of postoperative CT scan and hydrodynamic analysis.
Translated with www.DeepL.com/Translator (free version)
Key secondary outcomes
same as above
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
enhanced CT scan before operation
Interventions/Control_2
CABG
Interventions/Control_3
post operative CT scan
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Measuring WSS and OSI in coronary lesions
Measure WSS and OSI after bypass
Patients with good bypass blood flow
Key exclusion criteria
Complex coronary artery lesions
Patients with poor bypass blood flow
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Nakamura |
Organization
Saitama Cardiovascular and Respiratory Center
Division name
Cardiac surgery
Zip code
360-0197
Address
1696, Itai, Kumagaya, Saitama, Japan
TEL
0485369900
cardiacsurgken@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Nakamura |
Organization
Saitama Cardiovascular and Respiratory Center
Division name
Cardiac surgery
Zip code
360
Address
1696, Itai, Kumagaya, Saitama, Japan
TEL
09039023547
Homepage URL
cardiacsurgken@ybb.ne.jp
Sponsor or person
Institute
Saitama Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Cardiovascular and Respiratory Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Cardiovascular and Respiratory Center
Address
1696, Itai, Kumagaya, Saitama, Japan
Tel
09039023547
cardiacsurgken@ybb.ne.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
埼玉県立循環器呼吸器病センター
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 26 | Day |
Last modified on
| 2021 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051714
