Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke (SERICT-AIS)

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: Device: remote ischemic conditioning; Device: sham remote ischemic conditioning

Detailed Description

In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . 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): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Chang chun, Jilin, China, 130000
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1) Age≥18 years, < 80 years, regardless of sex;
• 2) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
• 3) Baseline NIHSS >= 5, and <= 25;
• 4) Baseline GCS ≥8;
• 5) Signed and dated informed consent is obtained

Exclusion Criteria:

• 1) Patients who undergo endovascular treatment;
• 2) mRS ≥ 2 before the onset of the disease;
• 3) Double upper limbs or lower limbs paralysis was found in this case;
• 4) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
• 5) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
• 6) Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
• 7) Severe organ dysfunction or failure;
• 8) Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
• 9) Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
• 10) Those who have a history of atrial fibrillation;
• 11) 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#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
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: RIC group; 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.	Device: remote ischemic conditioning; Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.
PLACEBO_COMPARATOR: control group; 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014	Device: 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 re-perfusion. 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
Frequency of adverse events during hospitalization	All adverse events until day-7 or discharge (whichever is earlier)	7 days
Frequency of adverse events during follow-up	Severe adverse events through day-90 after the onset of acute ischemic stroke.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge	National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge. Ranged from 0 to 42, a low value represents a better outcome.	7 days
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of hematological indicators	Hematological samples are collected at right before thrombolysis and 24 hours after thrombolysis, and changes of hematological indicators related to hemorrhagic transformation (such as Axl, ANGPTL4) are compared between the two groups.	24 hours
Changes of the function of dynamic cerebral autoregulation	The function of patients' dynamic cerebral autoregulation are tested 3 times within 10 days from onset and compared between the two groups.	10 days

Collaborators and Investigators

• Sponsor: Yi Yang

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): July 20, 2020

Study Registration Dates

• First Submitted: July 14, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (ACTUAL): July 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

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: SERICT-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