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

Launched by YI YANG · Sep 9, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called remote ischemic conditioning (RIC) to see if it is safe and effective for patients with carotid artery stenosis who are undergoing a procedure known as carotid endarterectomy. Carotid artery stenosis is when the arteries in your neck become narrowed, which can lead to serious health issues like strokes. The goal of the study is to find out if RIC can help improve outcomes for these patients.

To be eligible for this trial, participants need to be between 18 and 80 years old and have significant narrowing of the carotid artery, either with or without symptoms. They also need to be able to cooperate with a brain MRI scan and provide informed consent. However, people with certain conditions, like severe dementia or uncontrolled high blood pressure, won't be able to participate. If someone joins the study, they will receive the new treatment while being monitored to ensure their safety and well-being throughout the process.

Gender

ALL

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.