UMIN-CTR Clinical Trial

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
Email	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
Email	cardiacsurgken@ybb.ne.jp

Sponsor
Institute	Saitama Cardiovascular and Respiratory Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051714