Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

• Registration Number: NCT04980651
• Lead Sponsor: Yi Yang

Brief Summary

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.

Detailed Description

In this study, 2210 cases of ischemic stroke in 72 hours were 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 in treating acute ischemic stroke.

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-07-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-07-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2210

Inclusion Criteria

• 1. Age≥18 years, regardless of sex.
• 2. Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 72 hours of stroke onset.
• 3. Baseline NIHSS ≥ 4, ≤ 24.
• 4. Baseline mRS ≤ 2;
• 5. Signed and dated informed consent is obtained.

Exclusion Criteria

• 1. Patients who undergo thrombolytic therapy or endovascular treatment.
• 2. The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture, or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
• 3. Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumors,s and other diseases involving the brain.
• 4. Pregnant or lactating women.
• 5. Previous remote ischemic conditioning therapy or similar treatment.
• 6. Severe hepatic and renal dysfunction.
• 7. Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
• 8. Unwilling to be followed up or treated for poor compliance.
• 9. 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.
• 10. Other conditions that the researchers think are not suitable for the group.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIC+Standard medical treatment	Remote ischemic conditioning	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. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
Sham RIC+Standard medical treatment	Sham remote ischemic conditioning	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. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with modified Rankin Scale (mRS) Score 0-2.	3 months	Proportion of patients with modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.

Secondary Outcome Measures

Name	Time	Method
National Institute of Health stroke scale (NIHSS) at 7 days, 30±3 days, 90±3 days from onset.	7days, 30±3 days, 90±3 days	National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 42, a low value represents a better outcome.
modified Rankin Scale (mRS) Score at 7 days, 30±3 days, 90±3 days from onset.	7days, 30±3 days, 90±3 days	modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 6, a low value represents a better outcome.
Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset.	7days, 30±3 days, 90±3 days	Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 100, a high value represents a better outcome.
Proportion of patients with hemorrhagic transformation during hospitalization.	7 days	Proportion of patients with hemorrhagic transformation during hospitalization.
Frequency of adverse events during follow-up.	90 days	Severe adverse events through day-90 after the onset of acute ischemic stroke.

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China