Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy: A Pilot, Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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;
Locations
Other Locations
China
The First Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Yi Yang, MD, PhD
doctor_yangyi@163.com
0086-13756661217
Backup
Zhenni Guo, MD, PhD
zhen1ni2@163.com
Time Frame
Start Date: 2023-11-21
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 100
Treatments
Active_comparator: RIC+CEA+Standard medical treatment
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.
Placebo_comparator: Sham RIC+CEA+Standard medical treatment
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.
Related Therapeutic Areas
Sponsors
Leads: Yi Yang