Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Yi Yang
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Frequency of adverse events during follow-up
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.
Detailed Description
In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.
Investigators
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University
Eligibility Criteria
Inclusion Criteria
- •Age≥18 years, \< 80 years, regardless of sex;
- •Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
- •Baseline NIHSS \>= 5, and \<= 25;
- •Baseline GCS ≥8;
- •Signed and dated informed consent is obtained
Exclusion Criteria
- •Patients who undergo endovascular treatment;
- •mRS ≥ 2 before the onset of the disease;
- •Double upper limbs or lower limbs paralysis was found in this case;
- •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;
- •Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
- •Severe organ dysfunction or failure;
- •Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
- •Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
- •Those who have a history of atrial fibrillation;
Outcomes
Primary Outcomes
Frequency of adverse events during follow-up
Time Frame: 3 months
Severe adverse events through day-90 after the onset of acute ischemic stroke.
Frequency of adverse events during hospitalization
Time Frame: 7 days
All adverse events until day-7 or discharge (whichever is earlier)
Secondary Outcomes
- National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge(7 days)
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2(3 months)