The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency

Acute Ischemic Stroke Clinical Trial

— RIC-SIID  

Official title:

The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069546
• Other study ID #: RIC-SIID
• Status: Completed
• Phase: N/A
• Start date: September 7, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: December 2020
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Immunologic Deficiency Syndromes
• Ischemia
• Stroke

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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	XI Cheng District,

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of mHLA-DR level in plasma	through flow cytometry	change from baseline to 2(±24h)days, and at 7(±24h)days after admission
Secondary	The changes of TLR-2, TLR-4 level in plasma	through flow cytometry	change from baseline to 2(±24h)days, and at 7(±24h)days after admission
Secondary	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	within 7(±24h)days after admission
Secondary	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	90( ±7days) days after ischemic stroke onset
Secondary	White blood cell count, monocyte count	through routine blood test	baseline, 2(±24h) days, 7(±24h) days after admission
Secondary	Concentration of IL-1ß?IL-6?IL-10?TNFa(CRP if patients are infected)level	inflammatory cytokines	baseline, 2(±24h)days, and at 7(±24h)days after admission
Secondary	Number of Participants with Favorable outcome at 90 days	definition of favorable outcome: mRS : 0-2 or NIHSS: 0-1	90 days after ischemic stroke onset
Secondary	Number of Participants with any adverse events	adverse events include stroke extension, gastrointestinal bleed, cardiac events, increased liver or renal enzymes, and transfer to intensive care unit.	during baseline to 90 days after stroke onset