Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Undergoing Carotid EndArterectomy (SERIC-CASCEA)

Yi Yang

Status: Completed

Conditions: Carotid Artery Stenosis

Treatments: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT06033963

SERIC-CASCEA

Details and patient eligibility

About

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.

Full description

In this study, 100 patients with carotid artery stenosis undergoing carotid endarterectomy are included in our center in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups will be followed up for 1 year to evaluate the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis undergoing carotid endarterectomy.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

RIC+CEA+Standard medical treatment

Active Comparator group

Description:

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.

Treatment:

Procedure: Remote ischemic conditioning

Sham RIC+CEA+Standard medical treatment

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Sham remote ischemic conditioning