UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046225 |
|---|---|
| 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 | 2026/06/14 22:40:47 |
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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
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
hoshino.takao@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
Clinical and Academic Research Promotion Center, Tokyo Women's Medical University
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
Tel
0333538112
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
https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.946431/full
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jat/advpub/0/advpub_66105/_article
Number of participants that the trial has enrolled
79
Results
Among the 79 patients (mean age, 65.0 years, 40 women), 7 (16.3%) in the RIC group and 8 (22.2%) in the control group had good functional outcomes (odds ratio, 0.73 [95% confidence interval, 0.29-1.82]; P = 0.502). The incidences of major adverse cardiovascular events, aspiration pneumonia, and serious adverse events were similar in both the groups.
Results date posted
| 2026 | Year | 06 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age (standard deviation [SD]) was 71.9 (12.6) years. Approximately 70% were male, and the mean NIHSS score (SD) was 9.0 (4.0). In terms of stroke severity, the number of patients in the mild (NIHSS scores 5-9), moderate (NIHSS scores 10-14), and severe (NIHSS scores 15-20) groups were 51, 10, and 18, respectively. Of the patients, 25.3% and 16.5% received alteplase and endovascular treatment, respectively, before enrollment. Major vessel lesions were present in 35.4% of the patients. Among the 79 patients, 23, 20, 9, 18, and 9 had cardiac embolism, atherosclerotic brain infarction, small vessel disease, other etiology, and unknown etiology, respectively.
Participant flow
A total of 79 patients were enrolled in the study. They were assigned to the RIC group (N = 43) or the control group (N =36).
Adverse events
The incidence of serious adverse events such as recurrent ischemic stroke, intracerebral hemorrhage, ventricular fibrillation, sick sinus syndrome, suicide, new-onset malignant neoplasm, and gastrointestinal bleeding were similar in both groups.
Outcome measures
The primary endpoint was a good functional outcome 90 days after stroke onset, with target mRS scores of 0-1, 0-2, and 0-3 in the mild, moderate, and severe groups, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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 | 05 | Month | 31 | 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
| 2026 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052753
