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

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

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: remote ischemic conditioning

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • XI Cheng District,
    • Beijing, XI Cheng District,, China, 100053
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
White blood cell count, monocyte count	through routine blood test	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	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	90 days after ischemic stroke onset
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

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2019
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 24, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Remote ischemic preconditioning; Acute Ischemic Stroke; inflammation response; Stroke-induced immunodeficiency; Stroke-associated Pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Stroke; Ischemic Stroke; Ischemia; Immunologic Deficiency Syndromes
• Other Study ID Numbers: RIC-SIID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No