UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of blood flow in the internal thoracic artery at the upper extremity of the hemodialysis AVF
Acronym	Ipsilateral ITA in hemodialysis
Scientific Title	Evaluation of blood flow in the internal thoracic artery at the upper extremity of the hemodialysis AVF
Scientific Title:Acronym	Ipsilateral ITA in hemodialysis
Region	Japan

Condition
Condition	chronic kidney disease
Classification by specialty	Cardiology Vascular surgery Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the appropriateness of using the internal thoracic artery of a patient with a dialysis AVF in coronary artery bypass surgery, a treatment for angina pectoris, ischemic cardiomyopathy, and myocardial infarction. To date, the use of the internal thoracic artery in patients with hemodialysis AVFs has been controversial and inconclusive. We will measure blood flow in the internal thoracic artery and AVF in this study to determine the relationship between the two.
Basic objectives2	Others
Basic objectives -Others	We believe there is a close relationship between the AVF and the ipsilateral internal thoracic artery since they both receive blood flow from the same vessel. Identifying this relationship will significantly assist in preoperative anastomotic planning and intraoperative troubleshooting in coronary artery bypass graft surgery. It may also help to evaluate the function of the AVF.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Finding the FV cutoff value for the difference and ratio between pre-Qm and post-Qm
Key secondary outcomes	Correlation between age, sex, body surface area, cardiac function, and blood flow in internal thoracic arteries

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
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patient must be on dialysis 2) AVF must have already been constructed.
Key exclusion criteria	1) Previous coronary artery bypass surgery 2) AVF occlusion or impending occlusion (FV < 300 mL/min) 3) Immediately after VAIVT or AVF surgery 4) Occlusion of internal thoracic artery 5) AVG in the brachial loop
Target sample size	35

Research contact person
Name of lead principal investigator	1st name JIEN Middle name Last name SAITO
Organization	Nagoya City University East Medical Center
Division name	Cardiovascular Surgery
Zip code	464-8547
Address	1-2-23 Wakamizu, Chikusa-ku Nagoya, Aichi, Japan
TEL	0527217171
Email	jien0708@yahoo.co.jp

Public contact
Name of contact person	1st name JIEN Middle name Last name SAITO
Organization	Masuko Memorial Hospital
Division name	medical office
Zip code	453-8566
Address	35-28 Takebashi-cho, Nakamura-ku, Nagoya-shi, Aichi, Japan
TEL	052-451-1307
Homepage URL
Email	jien0708@yahoo.co.jp

Sponsor
Institute	Masuko Memorial Hospital
Institute
Department

Funding Source
Organization	Masuko Memorial Hospital
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	Masuko Memorial Hospital
Address	35-28 Takebashi-cho, Nakamura-ku, Nagoya-shi, Aichi, Japan
Tel	052-451-1307
Email	jien0708@yahoo.co.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	2022 Year 08 Month 24 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	Open public recruiting
Date of protocol fixation	2021 Year 12 Month 31 Day
Date of IRB	2022 Year 05 Month 11 Day
Anticipated trial start date	2022 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	nothing in particular

Management information
Registered date	2022 Year 08 Month 24 Day
Last modified on	2022 Year 08 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055537