The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency

NCT04069546 | Completed DMC

• 1 other identifier: RIC-SIID
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Remote ischemic preconditioning; Stroke-induced immunodeficiency; Stroke-associated Pneumonia; inflammation response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The changes of TLR-2, TLR-4 level in plasma

  change from baseline to 2(±24h)days, and at 7(±24h)days after admission

• Incidence of Stroke-associated Pneumonia within 1 week

  within 7(±24h)days after admission

• Number of Participants with physician-diagnosed pneumonia within 90 days after stroke onset

  90( ±7days) days after ischemic stroke onset

• White blood cell count, monocyte count

  baseline, 2(±24h) days, 7(±24h) days after admission

• 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

Study Arms (2)

AIS-RIC

EXPERIMENTAL

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

AIS

NO INTERVENTION

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

Interventions

remote ischemic conditioning DEVICE

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.

AIS-RIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, XI Cheng District,, 100053, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: September 7, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: December 28, 2020

Record last verified: 2020-12

Locations

CN (1)