Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: remote ischemic conditioning; Device: sham remote ischemic conditioning

• Registration Number: NCT04027621
• Lead Sponsor: Yi Yang

Brief Summary

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.

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 Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-14
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-22
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIC group	remote ischemic conditioning	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.
control group	sham remote ischemic conditioning	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

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events during follow-up	3 months	Severe adverse events through day-90 after the onset of acute ischemic stroke.
Frequency of adverse events during hospitalization	7 days	All adverse events until day-7 or discharge (whichever is earlier)

Secondary Outcome Measures

Name	Time	Method
National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge	7 days	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.
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2	3 months	Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Chang chun, Jilin, China