The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency

Capital Medical University46 enrolled

Overview

to detect the effects of RIC on stroke-induced immunodeficiency and inflammation response in acute ischemic stroke patients

Remote ischemic conditioning, consisting of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer systemic protection against prolonged ischemia in a distant organ. Numerous reports have confirmed its strongest endogenous neuroprotection against brain injury after stroke, of which the immune mechanisms are majorly involved in RIC. At the same time, the inflammation response plays a great role in stroke development, which may expand the infarct area. Stroke-induced immunodeficiency can potentiate stroke-associated pneumonia, which is an important cause of death after strokes. In this study, the investigators will assess the effect of RIC on stroke-induced immunodeficiency and inflammation response in AIS patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Acute Ischemic Stroke

Interventions

remote ischemic conditioningDEVICE

RIC is a physical strategy performed by an electric device with cuffs placed on the unilateral arm and inflated to 180 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age≥18 years old; * Confirmed diagnosis of acute ischemic stroke(AIS) with onset of symptoms within 48h at recruitment; * NIHSS score: ≤15; * Prestroke modified Rankin Scale(mRS) ≤2; * subject or his or her legally authorized representative was able to provide informed consent. Exclusion Criteria: * uncontrolled hypertension (defined as systolic blood pressure ≥200 mmHg); * participation in another device or drug trial simultaneously; * any vascular, soft tissue, or orthopedic injury (eg, superficial wounds and fractures of the arm) that contraindicated unilateral arm ischemic preconditioning; * peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion); * Women who have a positive pregnancy test; * History of malignancies; * Using remote ischemic conditioning within the preceding 1 week; * known infection at admission; * a history of infection or the use of antibiotics, immunosuppressants, or steroids within the preceding 3 months. * Other conditions are not suitable for this trial (evaluated by researchers)

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, XI Cheng District,, China

Outcomes

Primary Outcomes

The changes of mHLA-DR level in plasma

through flow cytometry

Time frame: change from baseline to 2(±24h)days, and at 7(±24h)days after admission

Secondary Outcomes

The changes of TLR-2, TLR-4 level in plasma

through flow cytometry

Time frame: change from baseline to 2(±24h)days, and at 7(±24h)days after admission

Incidence of Stroke-associated Pneumonia within 1 week

Stroke-associated Pneumonia diagnostic criteria base on the consensus of 2015 Stroke-associated Pneumonia diagnostic criteria base on the consensus of 2015 Stroke-associated Pneumonia diagnostic criteria base on the consensus of 2015

Time frame: within 7(±24h)days after admission

Number of Participants with physician-diagnosed pneumonia within 90 days after stroke onset

Number of Participants with Physician-diagnosed Pneumonia within 90 days after stroke onset Physician-diagnosed Pneumonia within 90 days

Time frame: 90( ±7days) days after ischemic stroke onset

White blood cell count, monocyte count

through routine blood test

Time frame: baseline, 2(±24h) days, 7(±24h) days after admission

Concentration of IL-1β、IL-6、IL-10、TNFα（CRP if patients are infected）level

inflammatory cytokines

Time frame: baseline, 2(±24h)days, and at 7(±24h)days after admission

Number of Participants with Favorable outcome at 90 days

definition of favorable outcome: mRS : 0-2 or NIHSS: 0-1

Data from ClinicalTrials.gov

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