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

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote ischemic conditioning
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke, Remote ischemic preconditioning, Stroke-induced immunodeficiency, Stroke-associated Pneumonia, inflammation response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Xuanwu Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AIS-RIC

AIS

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The changes of mHLA-DR level in plasma
through flow cytometry

Secondary Outcome Measures

The changes of TLR-2, TLR-4 level in plasma
through flow cytometry
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
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
White blood cell count, monocyte count
through routine blood test
Concentration of IL-1β、IL-6、IL-10、TNFα（CRP if patients are infected）level
inflammatory cytokines
Number of Participants with Favorable outcome at 90 days
definition of favorable outcome: mRS : 0-2 or NIHSS: 0-1
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.

Full Information

First Posted
August 23, 2019
Last Updated
December 24, 2020
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04069546
Brief Title
The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency
Acronym
RIC-SIID
Official Title
The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 7, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Acute Ischemic Stroke, Remote ischemic preconditioning, Stroke-induced immunodeficiency, Stroke-associated Pneumonia, inflammation response

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIS-RIC
Arm Type
Experimental
Arm Description
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.
Arm Title
AIS
Arm Type
No Intervention
Arm Description
This group of patients received regular therapy of acute ischemic stroke.
Intervention Type
Device
Intervention Name(s)
remote ischemic conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
The changes of mHLA-DR level in plasma
Description
through flow cytometry
Time Frame
change from baseline to 2(±24h)days, and at 7(±24h)days after admission
Secondary Outcome Measure Information:
Title
The changes of TLR-2, TLR-4 level in plasma
Description
through flow cytometry
Time Frame
change from baseline to 2(±24h)days, and at 7(±24h)days after admission
Title
Incidence of Stroke-associated Pneumonia within 1 week
Description
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
Time Frame
within 7(±24h)days after admission
Title
Number of Participants with physician-diagnosed pneumonia within 90 days after stroke onset
Description
Number of Participants with Physician-diagnosed Pneumonia within 90 days after stroke onset Physician-diagnosed Pneumonia within 90 days
Time Frame
90( ±7days) days after ischemic stroke onset
Title
White blood cell count, monocyte count
Description
through routine blood test
Time Frame
baseline, 2(±24h) days, 7(±24h) days after admission
Title
Concentration of IL-1β、IL-6、IL-10、TNFα（CRP if patients are infected）level
Description
inflammatory cytokines
Time Frame
baseline, 2(±24h)days, and at 7(±24h)days after admission
Title
Number of Participants with Favorable outcome at 90 days
Description
definition of favorable outcome: mRS : 0-2 or NIHSS: 0-1
Time Frame
90 days after ischemic stroke onset
Title
Number of Participants with any adverse events
Description
adverse events include stroke extension, gastrointestinal bleed, cardiac events, increased liver or renal enzymes, and transfer to intensive care unit.
Time Frame
during baseline to 90 days after stroke onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
XI Cheng District,
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

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The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency

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