UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048748 |
|---|---|
| Receipt number | R000055537 |
| Scientific Title | Evaluation of blood flow in the internal thoracic artery at the upper extremity of the hemodialysis AVF |
| Date of disclosure of the study information | 2022/08/24 |
| Last modified on | 2022/08/24 20:27:59 |
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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
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
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
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
jien0708@yahoo.co.jp
Sponsor or person
Institute
Masuko Memorial Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055537
