REMOTE ISCHEMIC CONDITIONING FOR ACUTE ISCHEMIC STROKE Part 2

REMOTE ISCHEMIC CONDITIONING FOR ACUTE ISCHEMIC STROKE Part 2 - RICAIS Part2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000046225

Enrollment

400

Registered

2021-11-29

Start date

2021-12-01

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

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

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 day

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactTakao Hoshino

Tokyo Women's Medical University Department of Neurology

hoshino.takao@twmu.ac.jp0333538111

Outcome results

None listed

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