UMIN-CTR Clinical Trial

Basic information
Public title	REMOTE ISCHEMIC CONDITIONING OR ACUTE ISCHEMIC STROKE-Study Protocol for a Randomized Controlled Trial
Acronym	RICAIS
Scientific Title	REMOTE ISCHEMIC CONDITIONING OR ACUTE ISCHEMIC STROKE-Study Protocol for a Randomized Controlled Trial
Scientific Title:Acronym	RICAIS
Region	Japan

Condition
Condition	ischemic stroke
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the efficacy of an RIC protocol based on recent literature, determined by the mRS score at 90 days after stroke onset, with a good outcome defined according to the severity at enrollment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	good functional outcome at 3-months after stroke onset, assessed by the mRS, with a target mRS score of 0-1 in the mild group, 0-2 in the moderate group, and 0-3 in the severe group.
Key secondary outcomes	1) the proportion of patients with a good functional outcome (assessed by the mRS) in each group at 3 months after stroke onset; 2) the change in NIHSS scores from before RIC to after RIC; 3) the incidence of major adverse cardiovascular events, aspiration pneumonia, and all-cause mortality after stroke onset; 4) the frequency of adverse RIC-related events; and 5) the proportion of patients with a mRS score of 0-1.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Intervention group: a manual blood pressure cuff will be placed around the lower leg or thigh of the unaffected side, and blood pressure will be measured while detecting the dorsalis pedis artery using an ultrasonic Doppler blood flow meter. The intervention (RIC) group will receive four cycles of 5 min of blood pressure cuff inflation, followed by 5 min of reperfusion. Cuff inflation in the RIC group will be at 200 mmHg or 50 mmHg above the systolic blood pressure; however, if the patient cannot tolerate this, the cuff pressure may be 180 mmHg. This procedure will be performed once daily after enrollment, for a minimum of 3 days and a maximum of 7 days. Discomfort and pain will be assessed using a visual analog scale (scale range: 1-10, with 0 indicating no pain and 10 indicating maximum pain).
Interventions/Control_2	Control group: a manual blood pressure cuff will be placed around the lower leg or thigh of the unaffected side, and blood pressure will be measured while detecting the dorsalis pedis artery using an ultrasonic Doppler blood flow meter. The control group will only undergo blood pressure measurements before and after the intervention period (the 40 mins required for four cycles of RIC).
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Written informed consent [patient or legal representative] 2 Male and Female patients [20<= age <= 90 years] 3 Diagnosed acute ischemic stroke by performing brain MRI and/or CT 4 Within 48 hours after stroke onset 5 NIHSS scores range from 5-20 at registration 6 Systolic blood pressure of upper and lower limbs is tolerable and systolic blood pressure is less than 180 mmHg
Key exclusion criteria	1 mRS is more than 2 before stroke onset 2 rt-PA and/or EVT treated AIS after registration 3 Within 12 hours after rt-PA administration or EVT 4 History of PAD 5 Systric blood pressure is more than 180 mmHg 6 Patients deemed unsuitable as subjects by the investigator
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Kitagawa
Organization	Tokyo Women's Medical University
Division name	department of neurology
Zip code	162-8666
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	richais.eb@twmu.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Ishizuka
Organization	Tokyo Women's Medical University
Division name	department of neurology
Zip code	162-8666
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	ricais.eb@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Charitable Trust Mihara Cerebrovascular Disorder Research Promotion Fund
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Women's Medical University IRB
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo , Japan
Tel	03-3353-8111
Email	Krinri.bm@twmu.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	東京女子医科大学病院 (東京都) 川崎医科大学病院 (岡山県) 大阪大学医学部附属病院 (大阪府) 大阪急性期・総合医療センター (大阪府) 東京女子医科大学八千代医療センター (千葉県) 戸田中央総合病院 (埼玉県) さいたま赤十字病院　(埼玉県) 公立昭和病院 (東京都) 国立病院機構大阪医療センター (大阪府) 日本医科大学付属病院 (東京都)

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 16 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	Completed
Date of protocol fixation	2020 Year 06 Month 06 Day
Date of IRB	2020 Year 09 Month 17 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2021 Year 08 Month 17 Day
Date of closure to data entry	2021 Year 08 Month 17 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	We have completed this study because insurance table was revealed.

Management information
Registered date	2021 Year 06 Month 16 Day
Last modified on	2021 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050139