Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Ischemic Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Yi Yang
- Enrollment
- 912
- Locations
- 1
- Primary Endpoint
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
he purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.
Detailed Description
In this study, 912 cases of ischemic stroke in 48 hours were included in 5 centers in China according to the principle of random, double-blind and parallel control .The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days .The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day, 7 days in a row . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning therapy.
Investigators
Yi Yang
Clinical Trial and Research Center for Stroke
The First Hospital of Jilin University
Eligibility Criteria
Inclusion Criteria
- •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；
- •5）Signed and dated informed consent is obtained
Exclusion Criteria
- •Patients with suspected posterior circulation infarction；
- •Patients who undergo thrombolytic therapy or endovascular treatment；
- •mRS≥2 score before the onset of the disease；
- •Double upper limbs or lower limbs paralysis was found in this case；
- •5）Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on；
- •Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain；
- •Treated blood pressure ≤90mmHg/60mmHg or≥180mmHg/100mmHg；
- •Severe organ dysfunction or failure；
- •Persons suffering from severe hematological diseases or severe coagulation disorder dysfunction；
- •Those who had a history of severe trauma or had major surgery within 6 months prior to admission；
Outcomes
Primary Outcomes
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
Time Frame: 3 months
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.
Secondary Outcomes
- NIHSS Score at end of 7th day of treatment(7 days)
- Changes of hematological indicators(48h; 7days)
- mRS Score at end of 7th day of treatment(7 days)
- Barthel Index at end of 7th day of treatment(7 days)