Status:
UNKNOWN
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy
Lead Sponsor:
Yi Yang
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.
Detailed Description
In this study, 100 patients with carotid artery stenosis receiving carotid endarterectomy are included in our center in China according to the principle of random, and parallel control. The experiment...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06033963
Start Date
November 21 2023
End Date
March 31 2025
Last Update
November 22 2023
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000