Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation

Yi Yang

Status: Completed

Conditions: Acute Ischemic Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04977869

SERIC-EVT

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.

Full description

In this study, 498 cases of ischemic stroke who undergo endovascular thrombectomy within 24 hours from the onset are included in 10 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 for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.

Enrollment: 498 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Age ≥ 18 years, male or female
• 2. Diagnosis of acute ischemic stroke within 24 hours of symptom onset and underwent endovascular thrombectomy (EVT) adhering to current guidelines for large vessel occlusion in the anterior circulation (confirmed by computed tomography angiography or digital subtraction angiography)
• 3. Pre-EVT NIHSS ≥ 6
• 4. Premorbid mRS ≤ 2
• 5. Written informed consent obtained from the patient or legally responsible person

Exclusion criteria

• 1. Contraindication of endovascular thrombectomy
• 2. Contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, and subclavian steal syndrome
• 3. Head CT showing cerebral hernia and midline displacement
• 4. Pregnancy or lactation
• 5. Previous remote ischemic conditioning therapy or similar treatment
• 6. Severe hepatic and renal dysfunction
• 7. Life expectancy of less than 3 months or inability to complete the study for other reasons
• 8. Unwilling to be followed up or poor compliance
• 9. Current or past participation in other clinical research, or participation in this study within 3 months prior to admission
• 10. Other conditions that the researchers think make the patient unsuitable for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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498 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 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.

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 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.

Treatment:

Procedure: Sham remote ischemic conditioning