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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046225
Receipt No. R000052753
Scientific Title REMOTE ISCHEMIC CONDITIONING FOR ACUTE ISCHEMIC STROKE Part 2
Date of disclosure of the study information 2021/11/29
Last modified on 2021/11/29

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Basic information
Public title REMOTE ISCHEMIC CONDITIONING FOR ACUTE ISCHEMIC STROKE Part 2
Acronym RICAIS Part2
Scientific Title REMOTE ISCHEMIC CONDITIONING FOR ACUTE ISCHEMIC STROKE Part 2
Scientific Title:Acronym RICAIS Part2
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effect of remote ischemic conditioning on clinical outcomes in patients with acute ischemic stroke
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Good functional prognosis at 90 days defined as modified Rankin Scale (mRS) score of 0-1, 0-2, and 0-3 for patients with mild, moderate, and severe stroke, respectively
Key secondary outcomes 1. Good functional prognosis at 90 days in each of mild, moderate, and severe stroke groups
2. Changes in NIHSS score before and after treatment
3. Occurrence of major adverse cardiovascular events (nonfatal stroke [either ischemic or hemorrhagic], nonfatal acute coronary syndrome, major peripheral artery disease, vascular death), aspiration pneumonia, any death during follow-up
4. Adverse events associated with remote ischemic conditioning procedures, including pain, numbness, eruption in lower limb, headache, nausea, changes in blood pressure
5. mRS 0-1 in entire study population

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 For all patients, 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 reduced to 180 mmHg. This procedure will be performed once daily after enrollment, for a minimum of 3 days and a maximum of 7 days (40 mins required for four cycles of RIC). 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 will only undergo blood pressure measurements before and after the intervention period of 40 min.
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. Patients hospitalized in participating institutions with written informed consent obtained from the patient or patient's representative
2. Male and female patients (19 < age < 90 years)
3. Diagnosed as acute ischemic stroke on the basis of brain MRI and/or CT findings
4. Within 48 hours after stroke onset
5. NIHSS scores range from 5 - 20 at registration
6. Tolerance to systemic blood pressure measurement and systolic blood pressure <180 mmHg
Key exclusion criteria 1. Premorbid mRS of 2 or more
2. Intravenous rt-PA and/or mechanical thrombectomy are planned after enrollment
3. Within 12 hours after rt-PA administration or mechanical thrombectomy
4. Systolic blood pressure >180 mmHg
5. History of PAD
6. Pregnant patients or patients suspected being pregnant
7. 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 1628666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL 0333538111
Email kitagawa.kazuo@twmu.ac.jp

Public contact
Name of contact person
1st name Takao
Middle name
Last name Hoshino
Organization Tokyo Women's Medical University
Division name Department of Neurology
Zip code 1628666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL 0333538111
Homepage URL
Email hoshino.takao@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 Clinical and Academic Research Promotion Center, Tokyo Women's Medical University
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
Tel 0333538112
Email rinri.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

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 29 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 18 Day
Date of IRB
2021 Year 11 Month 18 Day
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2024 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 29 Day
Last modified on
2021 Year 11 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052753

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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