UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053383 |
|---|---|
| Receipt number | R000060926 |
| Scientific Title | Novel nuclear imaging approach to assess perfusion and metabolism in chronic limb-threatening ischemia |
| Date of disclosure of the study information | 2024/01/20 |
| Last modified on | 2024/01/18 11:17:15 |
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Basic information
Public title
Developing nuclear imaging test in PAD
Acronym
Nuclear imaging in PAD
Scientific Title
Novel nuclear imaging approach to assess perfusion and metabolism in chronic limb-threatening ischemia
Scientific Title:Acronym
Nuclear imaging in CLTI
Region
| Japan |
Condition
Condition
peripheral artery disease
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to demonstrate proof-of-concept for a noninvasive method and novel parameters for assessing foot microcirculation and metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Limb fate including wound healing at 12-month
Key secondary outcomes
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with pedal tissue loss due to CLTI who have suspected coronary artery disease.
Key exclusion criteria
The patients with cognitive impairment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Hashimoto |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Vascular Surgery
Zip code
3500844
Address
1981 Kamoda, Kawagoe-city, Saitama, Japan
TEL
0492283400
takuya@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Hashimoto |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Vascular Surgery
Zip code
3500844
Address
1981 Kamoda, Kawagoe-city, Saitama, Japan
TEL
0492283400
Homepage URL
takuya@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Saitama Medical University
Address
38 Moro-Hongo, Moroyama-Town, Iruma-District, Saitama
Tel
049276214
rinri@saitama-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single center prospective cohort pilot study is planned. The lower limbs of the patients diagnosed with CLTI are subjected to radionuclide angiography and SPECT. Novel parameters is derived by processing the time activity curve of detected tracers at each region of interest in the limbs. The association of these two parameters with limb fate at one year is analyzed. The association with the transcutaneous partial oxygen pressure, a conventional perfusion test result, is analyzed.
Management information
Registered date
| 2024 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060926
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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