Clinical trial NCT04069546: The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency
Official title: The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
Remote ischemic preconditioning
Stroke-induced immunodeficiency
Stroke-associated Pneumonia
inflammation response
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The changes of mHLA-DR level in plasma
timeFrame: change from baseline to 2(±24h)days, and at 7(±24h)days after admission
Secondary outcomes:
measure: The changes of TLR-2, TLR-4 level in plasma
timeFrame: change from baseline to 2(±24h)days, and at 7(±24h)days after admission
measure: Incidence of Stroke-associated Pneumonia within 1 week
timeFrame: within 7(±24h)days after admission
measure: Number of Participants with physician-diagnosed pneumonia within 90 days after stroke onset
timeFrame: 90( ±7days) days after ischemic stroke onset
measure: White blood cell count, monocyte count
timeFrame: baseline, 2(±24h) days, 7(±24h) days after admission
measure: Concentration of IL-1β、IL-6、IL-10、TNFα（CRP if patients are infected）level
timeFrame: baseline, 2(±24h)days, and at 7(±24h)days after admission
measure: Number of Participants with Favorable outcome at 90 days
timeFrame: 90 days after ischemic stroke onset
measure: Number of Participants with any adverse events
timeFrame: during baseline to 90 days after stroke onset
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: XI Cheng District,
Study officials:
References: