Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke

NCT ID: NCT04980625

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-05-11

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, 558 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from the onset are included in 18 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 combined with intravenous thrombolysis in treating acute ischemic stroke.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 consecutive days from thrombolysis. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China.

Group Type: ACTIVE_COMPARATOR

Remote ischemic conditioning

Intervention Type: PROCEDURE

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.

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 consecutive days from thrombolysis. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China.

Group Type: PLACEBO_COMPARATOR

Sham remote ischemic conditioning

Intervention Type: PROCEDURE

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 inflations of a blood pressure cuff to 60 mm Hg.

Interventions

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.

Intervention Type: 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 inflations of a blood pressure cuff to 60 mm Hg.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1) Age≥18 years, regardless of sex;
• 2) Patients with a clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis with alteplase;
• 3) Pre-thrombolysis NIHSS >= 4, and <= 24;
• 4) Premorbid mRS 0-1;
• 5) Signed and dated informed consent is obtained;

Exclusion Criteria

• 1) Patients who have the contraindication of intravenous thrombolysis with alteplase.
• 2) 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.
• 3) Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
• 4) Pregnant or lactating women.
• 5) Severe hepatic and renal dysfunction.
• 6) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
• 7) Unwilling to be followed up or treated for poor compliance.
• 8) 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.
• 9) Other conditions that the researchers think are not suitable for the group.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi Yang

OTHER

Sponsor Role: lead

Responsible Party

Yi Yang

Associated Dean of First Hospital of Jilin University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

References

Guo ZN, Abuduxukuer R, Zhang P, Qu Y, Wang LJ, Zhao JF, Ju DS, Wang JM, Jin HM, Wang WW, Teng RH, Gao JH, Yuan ZM, Gao HF, Jiang YF, Li ZD, He Y, Jiang LG, Li L, Hu XF, Jiang CL, Wang R, Qi YB, Xin H, Jia Y, Yu H, Jin H, Chen HS, Wang DL, Nguyen TN, Yang Y; SERIC-IVT study group. Safety and Efficacy of Remote Ischemic Conditioning in Patients With Intravenous Thrombolysis: The SERIC-IVT Trial. Stroke. 2025 Feb;56(2):335-343. doi: 10.1161/STROKEAHA.124.048509. Epub 2025 Jan 8.

Reference Type: DERIVED

PMID: 39772709 (View on PubMed)

Other Identifiers

SERIC-IVT

Identifier Type: -

Identifier Source: org_study_id