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CompletedNCT06033963SERIC-CASCEAUpdated Feb 9, 2026

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Undergoing Carotid EndArterectomy

An interventional study of Remote ischemic conditioning and Sham remote ischemic conditioning in Carotid Artery Stenosis, sponsored by Yi Yang. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-09.

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

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis undergoing carotid endarterectomy.

Read the detailed description

In this study, 100 patients with carotid artery stenosis undergoing carotid endarterectomy are included in our center 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 6 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups will be followed up for 1 year to evaluate the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis undergoing carotid endarterectomy.

02

Conditions studied

  • Carotid Artery Stenosis

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Keywords

  • Remote ischemic conditioning
  • Carotid artery stenosis
  • Carotid endarterectomy
03

In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's enrollment of 100 is close to the median of 106 across 182 interventional studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

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.

04

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. Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 50% (Based on North American Symptomatic Carotid Endarterectomy Trial Collaborators (NASCET) Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria);
  3. Baseline mRS 0-2;
  4. Can cooperate with and complete brain magnetic resonance imaging (MRI) examination;
  5. Signed and dated informed consent is obtained;

Exclusion criteria

Exclusion Criteria:

  1. Evolving stroke;
  2. Chronic complete occlusion of the carotid artery without obvious symptoms of cerebral ischemia;
  3. Severe dementia;
  4. The causes of cardiogenic embolism, such as rheumatic mitral or aortic valve stenosis, artificial heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombosis or valve tumor, congestive heart failure, bacterial endocarditis, etc;
  5. Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, despite medication taken at enrollment);
  6. Severe hepatic and renal dysfunction (defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times higher than the upper limit of the normal range, creatinine >265umol/l (3mg/dl));
  7. 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;
  8. Pregnant or lactating women;
  9. 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;
  10. Other conditions that the researchers think are not suitable for the group.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    RIC+CEA+Standard medical treatment

    Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment. Additionally, the patients will be treated with carotid endarterectomy (CEA) and standard medical treatment according to the Chinese guideline for the secondary prevention of ischemic stroke and transient ischemic attack 2022.

    Procedure: Remote ischemic conditioning

  • Placebo comparator
    Sham RIC+CEA+Standard medical treatment

    Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment. Additionally, the patients will be treated with carotid endarterectomy (CEA) and standard medical treatment according to the Chinese guideline for the secondary prevention of ischemic stroke and transient ischemic attack 2022.

    Procedure: Sham remote ischemic conditioning

Interventions

  • ProcedureRemote ischemic conditioning

    Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.

  • ProcedureSham remote ischemic conditioning

    Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg.

06

What researchers measure

Primary outcomes

  1. Proportion of patients who got ≥1 new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.

    Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.

    Time frame: 6 days

Secondary outcomes

  1. The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.

    Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.

    Time frame: 6 days

  2. The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.

    Patients underwent magnetic resonance imaging(including DWI) at baseline and 6 days after randomization.

    Time frame: 6 days

  3. Number of patients with cerebrovascular events, cardiovascular events or death.

    Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.

    Time frame: 1 year

  4. Proportion of patients with any side effects of Remote ischemic conditioning (RIC) treatment.

    The side effects referred to any side effects of RIC or sham RIC treatment, not including the sides effect of medications and Carotid Endarterectomy (CEA).

    Time frame: 6 days

07

Study locations

1 site
  • The First Hospital of Jilin University
    Changchun, Jilin 130000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06033963
Lead sponsor
Yi Yang
Responsible party
Yi Yang (Associated Dean of First Hospital of Jilin University, The First Hospital of Jilin University) — Sponsor-investigator
First posted
Sep 13, 2023
Start date
Nov 20, 2023
Primary completion
Dec 11, 2024
Completion
Dec 11, 2025
Last update
Feb 9, 2026

Study contacts

Yi Yang, MD, PhD
study chair · Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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