Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Ischemic Stroke

NCT ID: NCT03669653

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 912 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2026-09-20

Brief Summary

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

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.

Conditions

Acute Ischemic Stroke

Study Design

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

Study Groups

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

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. RIC will be conducted twice daily for 7 days.

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

Group Type: PLACEBO_COMPARATOR

Sham 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 60 mm Hg. RIC will be conducted twice daily for 7 days.

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. RIC will be conducted twice daily for 7 days.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi Yang

OTHER

Sponsor Role: lead

Responsible Party

Yi Yang

Clinical Trial and Research Center for Stroke

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Central Contacts

Yi Yang, MD, PhD

Role: CONTACT

doctor_yangyi@163.com

0086-13756661217

Zhen-Ni Guo, MD

Role: CONTACT

zhen1ni2@163.com

Facility Contacts

Yi Yang, MD, PhD

Role: primary

doctor_yangyi@163.com

Other Identifiers

SERIC-AIS

Identifier Type: -

Identifier Source: org_study_id