UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044566 |
|---|---|
| Receipt number | R000050139 |
| Scientific Title | REMOTE ISCHEMIC CONDITIONING OR ACUTE ISCHEMIC STROKE-Study Protocol for a Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/06/16 |
| Last modified on | 2021/09/30 23:05:44 |
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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
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
ricais.eb@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050139
