Exploring remote ischemic conditioning for patients with carotid artery stenosis undergoing surgery

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy: A Pilot, Randomized Controlled Trial

This study is testing if a special treatment called remote ischemic conditioning can make surgery safer and more effective for people with narrowed carotid arteries.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT06033963 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis who are undergoing carotid endarterectomy. A total of 100 patients will be randomly assigned to either an experimental group receiving higher pressure remote ischemic conditioning or a control group receiving lower pressure conditioning, both for six consecutive days. The patients will be monitored for 90 days to assess the outcomes of the intervention. The goal is to determine if remote ischemic conditioning can improve patient safety and efficacy during the surgical procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with symptomatic or asymptomatic carotid artery stenosis meeting specific criteria.

Not a fit: Patients with evolving stroke, severe dementia, or certain cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance recovery and reduce complications for patients undergoing carotid endarterectomy.

How similar studies have performed: While remote ischemic conditioning has shown promise in other contexts, this specific application in carotid artery stenosis is relatively novel.

Eligibility criteria

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:

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.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (RECRUITING)

Study contacts

• Study coordinator: Yi Yang, MD, PhD

Conditions: Carotid Artery Stenosis, Remote ischemic conditioning, Carotid artery stenosis, Carotid endarterectomy