RIC-SIID: The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency

Sponsor

Capital Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04069546

Collaborator

(none)

Enrollment

Location

Arms

4.8

Actual Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Device: remote ischemic conditioning	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency

Actual Study Start Date :

Sep 7, 2019

Actual Primary Completion Date :

Feb 1, 2020

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AIS-RIC RIC is a physical strategy performed through 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. This group of patients received regular therapy of acute ischemic stroke plus unilateral arm of RIC intervention.	Device: remote 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.
No Intervention: AIS This group of patients received regular therapy of acute ischemic stroke.

Arm

Intervention/Treatment

Experimental: AIS-RIC

RIC is a physical strategy performed through 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. This group of patients received regular therapy of acute ischemic stroke plus unilateral arm of RIC intervention.

Device: remote 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.

No Intervention: AIS

This group of patients received regular therapy of acute ischemic stroke.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)