Acute Ischemic Stroke
Conditions
Keywords
Acute Ischemic Stroke, Remote ischemic preconditioning, Stroke-induced immunodeficiency, Stroke-associated Pneumonia, inflammation response
Brief summary
to detect the effects of RIC on stroke-induced immunodeficiency and inflammation response in acute ischemic stroke patients
Detailed description
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.
Interventions
DEVICEremote ischemic conditioning
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.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes of mHLA-DR level in plasma | change from baseline to 2(±24h)days, and at 7(±24h)days after admission | through flow cytometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Stroke-associated Pneumonia within 1 week | within 7(±24h)days after admission | 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 |
| Number of Participants with physician-diagnosed pneumonia within 90 days after stroke onset | 90( ±7days) days after ischemic stroke onset | Number of Participants with Physician-diagnosed Pneumonia within 90 days after stroke onset Physician-diagnosed Pneumonia within 90 days |
| White blood cell count, monocyte count | baseline, 2(±24h) days, 7(±24h) days after admission | through routine blood test |
| The changes of TLR-2, TLR-4 level in plasma | change from baseline to 2(±24h)days, and at 7(±24h)days after admission | through flow cytometry |
| Number of Participants with Favorable outcome at 90 days | 90 days after ischemic stroke onset | definition of favorable outcome: mRS : 0-2 or NIHSS: 0-1 |
| Number of Participants with any adverse events | during baseline to 90 days after stroke onset | adverse events include stroke extension, gastrointestinal bleed, cardiac events, increased liver or renal enzymes, and transfer to intensive care unit. |
| Concentration of IL-1β、IL-6、IL-10、TNFα（CRP if patients are infected）level | baseline, 2(±24h)days, and at 7(±24h)days after admission | inflammatory cytokines |
Countries
China
Outcome results
None listed