Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke

Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial

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.

In this study, 558 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from the onset are included in 18 centers in China according to the principle of random, 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 for 7 consecutive days. 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.

Inclusion Criteria:

• 1) Age≥18 years, regardless of sex;
• 2) Patients with a clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis with alteplase;
• 3) Pre-thrombolysis NIHSS >= 4, and <= 24;
• 4) Premorbid mRS 0-1;
• 5) Signed and dated informed consent is obtained;

Exclusion Criteria:

• 1) Patients who have the contraindication of intravenous thrombolysis with alteplase.
• 2) The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb.
• 3) Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
• 4) Pregnant or lactating women.
• 5) Severe hepatic and renal dysfunction.
• 6) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
• 7) Unwilling to be followed up or treated for poor compliance.
• 8) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission.
• 9) Other conditions that the researchers think are not suitable for the group.