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

Not Applicable

Completed

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

• Registration Number: NCT04980625
• Lead Sponsor: Yi Yang

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, 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.

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
• Primary Completion: 2023-05-11
• Study Completion: 2023-05-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 558

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIC+Standard medical treatment	Remote ischemic conditioning	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.
Sham RIC+Standard medical treatment	Sham remote ischemic conditioning	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1	3 months	Proportion of patients with Modified Rankin Scale (mRS) Score 0-1. Ranged from 0 to 6, a low value represents a better outcome.

Secondary Outcome Measures

Name	Time	Method
Frequency of adverse events during follow-up	90 days	All adverse events through 90 days.
Frequency of Hemorrhagic transformation within 24 hours after IVT.	24 hours	Frequency of Hemorrhagic transformation within 24 hours after IVT.
Barthel Index (BI) at 24 hours, and 7 days after IVT.	24 hours, 7 days	Barthel Index (BI) at 24 hours, and 7 days after IVT. Ranged from 0 to 100, a high value represents a better outcome.
National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT.	24 hours, 7 days	National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT. Ranged from 0 to 42, a low value represents a better outcome.
Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT.	90±3 days	Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT. mRS: Ranged from 0 to 6, a low value represents a better outcome.
Mortality within 90 days.	90 days	Mortality within 90 days.
Stroke recurrence rate within 90 days.	90 days	Stroke recurrence rate within 90 days.

Trial Locations

Locations (1)

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