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

Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: A Multicenter, Randomized, Parallel-controlled Clinical Trial

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.

Study Overview

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

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 498
• 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, male or female
• 2) Diagnosis of acute ischemic stroke due to large vessel occlusion of anterior circulation (large artery occlusion confirmed by head CTA or DSA) and history of emergent endovascular thrombectomy
• 3) Baseline 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

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; 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.	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; 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.	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
Frequency of adverse events during follow-up	Severe adverse events through day-90 after the onset of acute ischemic stroke.	90 days
Frequency of Hemorrhagic transformation during hospitalization	Frequency of Hemorrhagic transformation during hospitalization	7 days
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 42, a low value represents a better outcome.	24 hours, 7 days, 30±3 days, 90±3 days
Barthel Index (BI) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	Barthel Index (BI) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 100, a high value represents a better outcome.	24 hours, 7 days, 30±3 days, 90±3 days
modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days after EVT. Ranged from 0 to 6, a low value represents a better outcome.	24 hours, 7 days, 30±3 days, 90±3 days
The expanded Thrombolysis In Cerebral Infarction (eTICI) scale immediately after EVT	eTICI grade 0 is equivalent to no reperfusion or 0% filling of the downstream territory; eTICI 1 reflects thrombus reduction without any reperfusion of distal arteries; eTICI 2a is reperfusion in less than half or 1-49% of the territory; eTICI 2b50 is 50-66% reperfusion, exceeding the modified TICI (mTICI) 2B threshold but below the original TICI 2B cut-off point; eTICI 2b67 is 67-89% reperfusion, exceeding TICI but below TICI 2C; eTICI 2c is equivalent to TICI 2C or 90-99% reperfusion; and eTICI 3 is complete or 100% reperfusion, tantamount to TICI 3.	immediately after EVT
Vascular recanalization rate 24 hours after EVT	Vascular recanalization rate 24 hours after EVT	24 hours,

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of early withdrawal for safety or tolerability reasons	The number of early withdrawal for safety or tolerability reasons	7 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
Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	24 hours, 7 days, 30±3 days, 90±3 days
Heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	Heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after EVT.	24 hours, 7 days, 30±3 days, 90±3 days

Collaborators and Investigators

• Sponsor: Yi Yang

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 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-EVT

Drug and device information, study documents

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