UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049175 |
|---|---|
| Receipt number | R000056012 |
| Scientific Title | Investigation of the effect of ischemic preconditioning in CLTI patients using quantitative lower extremity arteriography. |
| Date of disclosure of the study information | 2022/10/14 |
| Last modified on | 2022/10/10 20:36:22 |
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Basic information
Public title
Investigation of the effect of ischemic preconditioning in CLTI patients using quantitative lower extremity arteriography.
Acronym
Investigation of the effect of ischemic preconditioning in CLTI patients using quantitative lower extremity arteriography.
Scientific Title
Investigation of the effect of ischemic preconditioning in CLTI patients using quantitative lower extremity arteriography.
Scientific Title:Acronym
Investigation of the effect of ischemic preconditioning in CLTI patients using quantitative lower extremity arteriography.
Region
| Japan |
Condition
Condition
chronic limb-threatening ischemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to apply this ischemic preconditioning to the lower extremity and develop a non-invasive method of improving lower extremity blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
DSA and 2DP angiography will be performed on the arteries below the knee in patients with CLTI. The lower leg will then be compressed with a manchette at a pressure of 200 mmHg for 5 minutes and then released for 5 minutes. 5 minutes of compression and release will be considered as one set, and DSA and 2DP angiography will be performed again after two sets to determine whether improvement in lower extremity blood flow is achieved.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
DSA and 2DP angiography will be performed on the below-knee artery in CLTI patients. The lower leg is then compressed with a manchette at a pressure of 200 mmHg for 5 minutes and then released for 5 minutes. 5 minutes of compression and release is one set, and DSA and 2DP angiography are performed again after two sets to see if improvement in blood flow is achieved.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study will include CLTI patients undergoing EVT to the below-knee artery at Toho University Medical Center Omori Hospital. If the patient has lesions in the iliac or femoral arteries, measurements will be taken at the time of EVT for the below-knee artery after EVT for the iliac and femoral arteries is performed.
Key exclusion criteria
Consent cannot be obtained in cases of inadequate judgment or unconsciousness, and therefore will not be included in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Noike |
Organization
Division of cardiovascular medicine, Department of internal medicine, Toho university faculty of medicine
Division name
cardiovascular medicine
Zip code
143-8541
Address
6-11-1Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
ryouta.noike@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Noike |
Organization
Department of internal medicine, Toho university faculty of medicine
Division name
cardiovascular medicine
Zip code
143-8541
Address
6-11-1Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
ryouta.noike@med.toho-u.ac.jp
Sponsor or person
Institute
Division of cardiovascular medicine, Department of internal medicine, Toho university faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Division of cardiovascular medicine, Department of internal medicine, Toho university faculty of medicine
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
Toho university faculty of medicine
Address
6-11-1Omorinishi, Ota-ku, Tokyo
Tel
03-3762-4151
ryouta.noike@med.toho-u.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
| 2022 | Year | 10 | Month | 14 | 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
| 2022 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 10 | Day |
Last modified on
| 2022 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056012
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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