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Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Ischemic Stroke

ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYi Yang

About this trial

he purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1）Age≥18 years, < 80 years, regardless of sex；

2）Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 12 hours of stroke onset

3）Baseline NIHSS score>5, and≤25 ；

4）GCS score ≥8；

Disqualifiers

1) Patients with suspected posterior circulation infarction；

2) Patients who undergo thrombolytic therapy or endovascular treatment；

3) mRS≥2 score before the onset of the disease；

4) Double upper limbs or lower limbs paralysis was found in this case；

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remote ischemic conditioning

    Procedure/Surgery

    Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days.

  • Sham remote ischemic conditioning

    Procedure/Surgery

    Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days.

Treatment groups

912 Participants
are divided into 2 treatment groups
Group A: RIC+Standard medical treatmentActive comparator 1 intervention
Group B: Sham RIC+Standard medical treatmentPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with Modified Rankin Scale (mRS) Score 0-2

The primary outcome measure of efficacy is the modified Rankin Scale (mRS) dichotomized to define good functional outcome as mRS 0-2 at 90 days.score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.

Time frame
3 months

Secondary outcomes

1

NIHSS Score at end of 7th day of treatment

NIHSS Score at end of 7th day of treatment

Time frame
7 days
2

mRS Score at end of 7th day of treatment

mRS Score at end of 7th day of treatment

Time frame
7 days
3

Barthel Index at end of 7th day of treatment

Barthel Index at end of 7th day of treatment

Time frame
7 days
4

Changes of hematological indicators

The changes of hematological indicators (inflammatory cytokine,et al.) between the first 48h and end of 7th day of treatment.

Time frame
48h; 7days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yi Yang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: