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

NCT03669653 | Not Yet Recruiting DMC

• 1 other identifier: SERIC-AIS
• Study Type: interventional
• Target: 912
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with Modified Rankin Scale (mRS) Score 0-2

  The primary outcome measure of efficacy is the modified Rankin Scale (mRS) dichotomized to define good functional outcome as mRS 0-2 at 90 days.score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.

  3 months

Secondary Outcomes (4)

• NIHSS Score at end of 7th day of treatment

  7 days

• mRS Score at end of 7th day of treatment

  7 days

• Barthel Index at end of 7th day of treatment

  7 days

• Changes of hematological indicators

  48h; 7days

Study Arms (2)

RIC+Standard medical treatment

ACTIVE COMPARATOR

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

Procedure: Remote ischemic conditioning

Sham RIC+Standard medical treatment

PLACEBO COMPARATOR

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

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 will be conducted twice daily for 7 days.

RIC+Standard medical treatment

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

Sham RIC+Standard medical treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）Age≥18 years, \< 80 years, regardless of sex；
• ）Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 12 hours of stroke onset
• ）Baseline NIHSS score\>5, and≤25 ；
• ）GCS score ≥8；
• ）Signed and dated informed consent is obtained

You may not qualify if:

• \) Patients with suspected posterior circulation infarction；
• \) Patients who undergo thrombolytic therapy or endovascular treatment；
• \) mRS≥2 score before the onset of the disease；
• \) Double upper limbs or lower limbs paralysis was found in this case；
• ）Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on；
• \) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain；
• \) Treated blood pressure ≤90mmHg/60mmHg or≥180mmHg/100mmHg；
• \) Severe organ dysfunction or failure；
• \) Persons suffering from severe hematological diseases or severe coagulation disorder dysfunction；
• \) Those who had a history of severe trauma or had major surgery within 6 months prior to admission；
• \) 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；
• \) Pregnant or lactating women；
• \) Previous remote ischemic conditioning therapy or similar treatment；
• \) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons；
• \) Severe hepatic and renal dysfunction

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yi Yang, MD, PhD

CONTACT

0086-13756661217; doctor_yangyi@163.com

Zhen-Ni Guo, MD

CONTACT

zhen1ni2@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Trial and Research Center for Stroke

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 13, 2018
• Study Start: June 17, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-02

Locations

CN (1)