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

NCT06033963 | Completed DMC

• 1 other identifier: SERIC-CASCEA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Artery Stenosis

Keywords

Remote ischemic conditioning; Carotid artery stenosis; Carotid endarterectomy

Outcome Measures

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.

  6 days

Secondary Outcomes (4)

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

  6 days

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

  6 days

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

  1 year

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

  6 days

Study Arms (2)

RIC+CEA+Standard medical treatment

ACTIVE COMPARATOR

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

Sham RIC+CEA+Standard medical treatment

PLACEBO COMPARATOR

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

Remote ischemic conditioning PROCEDURE

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.

RIC+CEA+Standard medical treatment

Sham remote ischemic conditioning PROCEDURE

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.

Sham RIC+CEA+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;
• 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);
• Baseline mRS 0-2;
• Can cooperate with and complete brain magnetic resonance imaging (MRI) examination;
• Signed and dated informed consent is obtained;

You may not qualify if:

• Evolving stroke;
• Chronic complete occlusion of the carotid artery without obvious symptoms of cerebral ischemia;
• Severe dementia;
• 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;
• Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, despite medication taken at enrollment);
• 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));
• 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;
• 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

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yi Yang, MD, PhD

  Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

  STUDY CHAIR

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: September 3, 2023
• First Posted: September 13, 2023
• Study Start: November 20, 2023
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

CN (1)