Safety and Efficacy of Remote Ischemic Conditioning in Patients with Chronic Internal Carotid Artery Occlusion Receiving Hybird Surgery: a Pilot, Randomized Controlled Trial (SERIC-HS)

The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Carotid Artery Occlusion
• Intervention / Treatment: Device: Remote ischemic conditioning; Device: Sham remote ischemic conditioning

Detailed Description

In this study, 60 patients with internal carotid artery occlusion receiving hybird surgery are included in our center in China. The experimental group will receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group will 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 90 days to evaluate the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang, MD, PhD; Phone Number: 0086-13756661217; Email: doctor_yangyi@163.com
• Study Contact Backup: Name: Zhenni Guo, MD, PhD; Email: zhen1ni2@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age≥18 years, regardless of sex
• Patients with chronic carotid artery occlusion who are going to undergo hybird surgery
• Can cooperate with and complete brain magnetic resonance imaging (MRI) examination
• Signed and dated informed consent is obtained

Exclusion Criteria:

• Hemorrhagic stroke
• Severe cardiac dysfunction or arrhythmia
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RIC; 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.	Device: Remote ischemic conditioning; Remote ischemic conditioning: 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 inflations of a blood pressure cuff to 200 mmHg.
Placebo Comparator: Sham RIC; Sham 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. Sham RIC will be conducted twice daily for 6 consecutive days after enrollment.	Device: Sham remote ischemic conditioning; Sham 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 inflations of a blood pressure cuff to 60 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with new Diffusion Weighted Imaging (DWI) - positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.	Patients will undergo magnetic resonance imaging (including DWI) at baseline and 6 days after randomization.	6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.	Patients will undergo magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.	6 days
The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.	Patients will undergo magnetic resonance imaging(including DWI) at baseline and 6 days after randomization.	6 days
Number of patients with cerebrovascular events, cardiovascular events or death	Cerebrovascular events include ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage. Cardiovascular events include angina and myocardial infarction. Death include all-cause of death.	90±7 days
Proportion of patients with any side effects of RIC treatment.	The side effects referred to any side effects of RIC or sham RIC treatment, not including the sides effect of medications or hybrid surgery.	6 days
Proportion of patients with any adverse events（including serious adverse events)	Adverse events due to any cause after enrollment of subjects in both groups.	90±7 days

Collaborators and Investigators

• Sponsor: Yi Yang
• Investigators: Study Chair: Yi Yang, MD, PhD, Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: remote ischemic conditioning; carotid artery occlusion; RIC; hybird surgery; interventional surgery
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: SERIC-HS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No