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Completed

NCT Number: NCT04069546

The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, XI Cheng District,, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. The changes of mHLA-DR level in plasma

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

    through flow cytometry

Secondary outcomes

  1. The changes of TLR-2, TLR-4 level in plasma

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

    through flow cytometry

  2. Incidence of Stroke-associated Pneumonia within 1 week

    Time frame: 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

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

    Time frame: 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

  4. White blood cell count, monocyte count

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

    through routine blood test

  5. Concentration of IL-1β、IL-6、IL-10、TNFα(CRP if patients are infected)level

    Time frame: baseline, 2(±24h)days, and at 7(±24h)days after admission

    inflammatory cytokines

  6. Number of Participants with Favorable outcome at 90 days

    Time frame: 90 days after ischemic stroke onset

    definition of favorable outcome: mRS : 0-2 or NIHSS: 0-1

  7. Number of Participants with any adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Acronym: RIC-SIID

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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