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

Yi Yang

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT04980625

SERIC-IVT

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 558 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

558 participants in 2 patient groups, including a placebo group

RIC+Standard medical treatment

Active Comparator group

Description:

RIC+Standard medical treatment 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 inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days from thrombolysis. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China.

Treatment:

Procedure: Remote ischemic conditioning

Sham RIC+Standard medical treatment

Placebo Comparator group

Description:

Sham RIC+Standard medical treatment 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 inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days from thrombolysis. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China.

Treatment:

Procedure: Sham remote ischemic conditioning