Efficacy Study II on Remote Ischemic Conditioning for the Prevention of Stroke-Associated Pneumonia (RICA-2)

Capital Medical University

Status: Completed

Conditions: Stroke

Treatments: Device: Sham remote ischemic conditioning; Device: Remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05982015

RICA-2

Details and patient eligibility

About

Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset

Full description

Verifying whether remote ischemic adaptation can reduce the occurrence and safety of stroke related pneumonia in acute stroke patients within 24 hours of onset

Enrollment: 1,651 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age≥18 years old;
• Diagnosis of acute ischemic stroke;
• Remote ischemic conditioning or sham-remote ischemic conditioning can be treated within 24 hours after stroke onset
• NIHSS score≥4;
• Subject or his or her legally authorized representative was able to provide informed consent.

Exclusion criteria

• During the screening period, body temperature ≥ 38 ℃;
• Evidence of lung infection, urinary tract infection or other infectious diseases during the screening period
• Expected lifespan less than 7 days
• Mechanical ventilation is expected to be required within 7 days;
• Anti-infective drug were used within 7 days prior to stroke;
• Uncontrolled hypertension with medication (defined as systolic blood pressure ≥200 mmHg and/or diastolic blood pressure ≥110 mmHg);
• There are contraindications for remote ischemic conditioning (such as skin and soft tissue injury, fractures, peripheral arterial disease, etc. in the upper limbs);
• History of autoimmune disease or malignancies;
• Use of immunosuppressive drug within the preceding 3 months;
• Pregnant or lactating, or pregnancy test positive;
• Current participation in another investigational trial;
• Other conditions are not suitable for this trial as evaluated by researchers.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,651 participants in 2 patient groups

Intervention group

Experimental group

Description:

Remote ischemic conditioning (RIC) -200mmHg and best medical management

Treatment:

Device: Remote ischemic conditioning

Sham group

Sham Comparator group

Description:

Remote ischemic conditioning (RIC) -60mmHg and best medical management

Treatment:

Device: Sham remote ischemic conditioning