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

Not Applicable

Not yet recruiting

• Conditions: Carotid Artery Occlusion

• Registration Number: NCT06702644
• Lead Sponsor: Yi Yang

Brief Summary

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.

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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26
• Study Start: 2024-12-01
• Primary Completion: 2026-11-30
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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