Unique ID issued by UMIN | UMIN000046225 |
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Receipt number | 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 | 2022/04/02 19:12:08 |
REMOTE ISCHEMIC CONDITIONING FOR ACUTE ISCHEMIC STROKE Part 2
RICAIS Part2
REMOTE ISCHEMIC CONDITIONING FOR ACUTE ISCHEMIC STROKE Part 2
RICAIS Part2
Japan |
Ischemic stroke
Neurology |
Others
NO
To evaluate the effect of remote ischemic conditioning on clinical outcomes in patients with acute ischemic stroke
Safety,Efficacy
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
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
Central registration
2
Treatment
Maneuver |
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)
Control group will only undergo blood pressure measurements before and after the intervention period of 40 min.
20 | years-old | <= |
90 | years-old | > |
Male and Female
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
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
400
1st name | Kazuo |
Middle name | |
Last name | Kitagawa |
Tokyo Women's Medical University
Department of Neurology
1628666
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
0333538111
kitagawa.kazuo@twmu.ac.jp
1st name | Takao |
Middle name | |
Last name | Hoshino |
Tokyo Women's Medical University
Department of Neurology
1628666
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
0333538111
hoshino.takao@twmu.ac.jp
Tokyo Women's Medical University
Charitable trust Mihara Cerebrovascular Disorder Research Promotion Fund
Non profit foundation
Clinical and Academic Research Promotion Center, Tokyo Women's Medical University
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
0333538112
rinri.bm@twmu.ac.jp
NO
2021 | Year | 11 | Month | 29 | Day |
Unpublished
Enrolling by invitation
2021 | Year | 11 | Month | 18 | Day |
2021 | Year | 11 | Month | 18 | Day |
2021 | Year | 12 | Month | 01 | Day |
2024 | Year | 03 | Month | 01 | Day |
2021 | Year | 11 | Month | 29 | Day |
2022 | Year | 04 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052753
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