CompletedNot Applicable

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

China100 participantsStarted 2023-11-20

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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;

What they're measuring

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

Timeframe: 6 days

Trial details

NCT IDNCT06033963

SponsorYi Yang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-11

View on ClinicalTrials.gov More Carotid Artery Stenosis trials