Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Ischemic Stroke (SERIC-AIS)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

Detailed Description

In this study, 912 cases of ischemic stroke in 48 hours were included in 5 centers in China according to the principle of random, double-blind 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, 7 days in a row . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning therapy.

• Study Type: Interventional
• Enrollment (Estimated): 912
• 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: Zhen-Ni Guo, MD; Email: zhen1ni2@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • 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 to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1）Age≥18 years, < 80 years, regardless of sex；
• 2）Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 12 hours of stroke onset
• 3）Baseline NIHSS score>5, and≤25 ；
• 4）GCS score ≥8；
• 5）Signed and dated informed consent is obtained

Exclusion Criteria:

• 1) Patients with suspected posterior circulation infarction；
• 2) Patients who undergo thrombolytic therapy or endovascular treatment；
• 3) mRS≥2 score before the onset of the disease；
• 4) Double upper limbs or lower limbs paralysis was found in this case；
• 5）Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on；
• 6) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain；
• 7) Treated blood pressure ≤90mmHg/60mmHg or≥180mmHg/100mmHg；
• 8) Severe organ dysfunction or failure；
• 9) Persons suffering from severe hematological diseases or severe coagulation disorder dysfunction；
• 10) Those who had a history of severe trauma or had major surgery within 6 months prior to admission；
• 11) 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；
• 12) Pregnant or lactating women；
• 13) Previous remote ischemic conditioning therapy or similar treatment；
• 14) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons；
• 15) Severe hepatic and renal dysfunction
• 16) Unwilling to be followed up or treated for poor compliance；
• 17) 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；
• 18) 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 inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days. Additionally,the patients will be treated with standard medical treatment according to 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 inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days.
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 inflations of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014	Procedure: 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 inflations of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days.

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	The primary outcome measure of efficacy is the modified Rankin Scale (mRS) dichotomized to define good functional outcome as mRS 0-2 at 90 days.score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS Score at end of 7th day of treatment	NIHSS Score at end of 7th day of treatment	7 days
mRS Score at end of 7th day of treatment	mRS Score at end of 7th day of treatment	7 days
Barthel Index at end of 7th day of treatment	Barthel Index at end of 7th day of treatment	7 days
Changes of hematological indicators	The changes of hematological indicators (inflammatory cytokine,et al.) between the first 48h and end of 7th day of treatment.	48h; 7days

Collaborators and Investigators

• Sponsor: Yi Yang

Study record dates

Study Major Dates

• Study Start (Estimated): June 17, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2026

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

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-AIS

Drug and device information, study documents

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