UMIN-CTR Clinical Trial

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
Email	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
Email	ryouta.noike@med.toho-u.ac.jp

Sponsor
Institute	Division of cardiovascular medicine, Department of internal medicine, Toho university faculty of medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056012