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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

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 Type: Interventional
• Enrollment (Actual): 558
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RIC+Standard medical treatment; 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.	Procedure: 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 inflations of a blood pressure cuff to 200 mm Hg.
Placebo Comparator: Sham RIC+Standard medical treatment; 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.	Procedure: Sham remote ischemic conditioning; Sham 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 inflations of a blood pressure cuff to 60 mm Hg.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scales (NRS) score during intervention.	Numeric rating scales (NRS) score during intervention. Ranged from 0 to 10, a low value represents a less pain.	7 days
Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	24 hours, 7 days, 30±3 days, 90±3 days
heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	24 hours, 7 days, 30±3 days, 90±3 days
The number of early withdrawal for safety or tolerability reasons	The number of early withdrawal for safety or tolerability reasons	7 days

Collaborators and Investigators

• Sponsor: Yi Yang

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): May 11, 2023
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: SERIC-IVT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No