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

NCT04980625 | Completed DMC

• 1 other identifier: SERIC-IVT
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with Modified Rankin Scale (mRS) Score 0-1

  Proportion of patients with Modified Rankin Scale (mRS) Score 0-1. Ranged from 0 to 6, a low value represents a better outcome.

  3 months

Secondary Outcomes (7)

• National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT.

  24 hours, 7 days

• Barthel Index (BI) at 24 hours, and 7 days after IVT.

  24 hours, 7 days

• Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT.

  90±3 days

• Frequency of adverse events during follow-up

  90 days

• Frequency of Hemorrhagic transformation within 24 hours after IVT.

  24 hours

Study Arms (2)

RIC+Standard medical 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 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.

Procedure: Remote ischemic conditioning

Sham RIC+Standard medical treatment

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 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.

Procedure: Sham remote ischemic conditioning

Interventions

Remote ischemic conditioning 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.

RIC+Standard medical treatment

Sham remote ischemic conditioning 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.

Sham RIC+Standard medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) Patients who have the contraindication of intravenous thrombolysis with alteplase.
• \) 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.
• \) Pregnant or lactating women.
• \) Severe hepatic and renal dysfunction.
• \) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
• \) Unwilling to be followed up or treated for poor compliance.
• \) 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.
• \) Other conditions that the researchers think are not suitable for the group.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Related Publications (1)

• 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.

  PMID: 39772709 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 28, 2021
• Study Start: July 1, 2021
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

CN (1)