Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke

Safety and Efficacy of Remote Ischemic Conditioning 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 for acute ischemic stroke.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 2210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang, MD, PhD; Phone Number: 0086-13756661217; Email: doctor_yangyi@163.com
• Study Contact Backup: Name: Zhenni Guo, MD, PhD; Email: zhen1ni2@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Yi Yang, MD,PHD; Email: doctor_yangyi@163.com

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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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. 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.	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 inflation of a blood pressure cuff to 200 mm Hg.
Placebo Comparator: 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. 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.	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 inflation 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 0-2.	Proportion of patients with modified Rankin Scale (mRS) Score 0-2. 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 7 days, 30±3 days, 90±3 days from onset.	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.	7days, 30±3 days, 90±3 days
modified Rankin Scale (mRS) Score at 7 days, 30±3 days, 90±3 days from onset.	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.	7days, 30±3 days, 90±3 days
Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset.	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.	7days, 30±3 days, 90±3 days
Proportion of patients with hemorrhagic transformation during hospitalization.	Proportion of patients with hemorrhagic transformation during hospitalization.	7 days
Frequency of adverse events during follow-up.	Severe adverse events through day-90 after the onset of acute ischemic stroke.	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days.	Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days.	24 hours, 7 days, 30±3 days, 90±3 days
heart rate at 24 hours, 7 days, 30±3 days, 90±3 days.	heart rate at 24 hours, 7 days, 30±3 days, 90±3 days.	24 hours, 7 days, 30±3 days, 90±3 days
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
Proportion of patients with early withdrawal for safety or tolerability reasons.	Proportion of patients with 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 (Estimated): July 1, 2025
• Study Completion (Estimated): October 1, 2025

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): October 2, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: February 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

Drug and device information, study documents

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