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REMOTE ISCHEMIC CONDITIONING OR ACUTE ISCHEMIC STROKE-Study Protocol for a Randomized Controlled Trial

REMOTE ISCHEMIC CONDITIONING OR ACUTE ISCHEMIC STROKE-Study Protocol for a Randomized Controlled Trial - RICAIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044566
Enrollment
400
Registered
2021-06-16
Start date
2021-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemic stroke

Interventions

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 usin
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. Discomfo

Sponsors

Tokyo Women's Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactKentaro Ishizuka

Tokyo Women's Medical University department of neurology

ricais.eb@twmu.ac.jp03-3353-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026