Not yet recruitingNCT03669653SERIC-AISUpdated Oct 2, 2024

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

An interventional study of Remote ischemic conditioning and Sham remote ischemic conditioning in Acute Ischemic Stroke, sponsored by Yi Yang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Yi Yang · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 912
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

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

Read the 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 studied

Acute Ischemic Stroke

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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 912 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

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Lead sponsor

Yi Yang is the lead sponsor of 41 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

1. Patients with suspected posterior circulation infarction；
1. Patients who undergo thrombolytic therapy or endovascular treatment；
1. mRS≥2 score before the onset of the disease；
1. 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；
1. Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain；
1. Treated blood pressure ≤90mmHg/60mmHg or≥180mmHg/100mmHg；
1. Severe organ dysfunction or failure；
1. Persons suffering from severe hematological diseases or severe coagulation disorder dysfunction；
1. Those who had a history of severe trauma or had major surgery within 6 months prior to admission；
1. 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；
1. Pregnant or lactating women；
1. Previous remote ischemic conditioning therapy or similar treatment；
1. Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons；
1. Severe hepatic and renal dysfunction
1. Unwilling to be followed up or treated for poor compliance；
1. 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；
1. Other conditions that the researchers think are not suitable for the group.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 912 participants (estimated)

Study arms

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 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
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 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

ProcedureRemote 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.
ProcedureSham 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.

What researchers measure

Primary outcomes

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.
Time frame: 3 months

Secondary outcomes

NIHSS Score at end of 7th day of treatment
NIHSS Score at end of 7th day of treatment
Time frame: 7 days
mRS Score at end of 7th day of treatment
mRS Score at end of 7th day of treatment
Time frame: 7 days
Barthel Index at end of 7th day of treatment
Barthel Index at end of 7th day of treatment
Time frame: 7 days
Changes of hematological indicators
The changes of hematological indicators (inflammatory cytokine,et al.) between the first 48h and end of 7th day of treatment.
Time frame: 48h; 7days

Study locations

1 site

First Hospital of Jilin University
Changchun, Jilin 130000, China
- Yi Yang, MD, PhD · Contact · doctor_yangyi@163.com

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03669653
Lead sponsor: Yi Yang
Responsible party: Yi Yang (Clinical Trial and Research Center for Stroke, The First Hospital of Jilin University) — Sponsor-investigator
First posted: Sep 13, 2018
Start date: Jun 17, 2025 (estimated)
Primary completion: Sep 20, 2026 (estimated)
Completion: Sep 20, 2026 (estimated)
Last update: Oct 2, 2024

Study contacts

Yi Yang, MD, PhD

Contact

doctor_yangyi@163.com

0086-13756661217

Zhen-Ni Guo, MD

Contact

zhen1ni2@163.com

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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