This study aims to explore the efficacy of Intermittent Hypoxia Treatment (IHT) in preventing peri-operative embolism-related microinfarcts among patients with severe internal carotid artery stenosis (ICAS) undergoing carotid artery stenting (CAS).
Study Objective:To explore the safety and efficacy of Intermittent Hypoxia Treatment (IHT) for the prevention of peri-operative embolism-induced microinfarcts in patients with severe internal carotid artery stenosis (ICAS) undergoing carotid artery stenting (CAS).Study Content:A proof-of-concept phase 2 randomized controlled trial will be conducted to analyze the safety and potential protective effects of IHT in patients with ICAS receiving stent implantation. Intermittent hypoxia treatment will be administered pre-operatively and post-operatively, and differences including the incidence of postoperative microinfarcts will be compared between the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
176
Patients receive intermittent hypoxia therapy twice daily (interval \> 6 hours) for at least 4 sessions consecutively before carotid artery stenting, and at least 2 consecutive sessions after the procedure. Each treatment consists of 4 cycles: each cycle comprises a hypoxic phase with inhalation of 13% O₂ for 10 minutes, followed by a normoxic phase with inhalation of 21% O₂ for 5 minutes, yielding a total duration of 60 minutes.
Patients receive standard carotid artery stenting.
Patients receive standard medical therapy including antiplatelet agents, statins, and risk factor control (blood pressure, HbA1c, LDL).
Oxygen Concentrator;Oxygen Mask
Beijing, Beijing Municipality, China
Incidence of ≥1 new cerebral lesion detected on brain diffusion-weighted imaging (DWI) within 48 hours after carotid artery stenting (CAS).
Time frame: Within 48 hours after carotid artery stenting
Incidence of acute cerebrovascular event within 1 month after CAS
Incidence of ischemic stroke, transient ischemic attack (TIA), hemorrhagic stroke and hyperperfusion syndrome within 1 month after CAS.
Time frame: Within 1 month after CAS
Number and volume of new cerebral lesions within 48 hours after CAS.
Number and volume of new cerebral lesions within 48 hours after CAS.
Time frame: Within 48 hours after CAS
Change in Heart Rate (HR) Within 72 Hours After CAS
Change in heart rate (HR) within 72 hours after CAS.
Time frame: Within 72 hours after surgery
Change in Peak Systolic Velocity (PSV) in Intracranial and Extracranial Arteries Measured by Ultrasound From Baseline to Within 72 Hours After CAS
Change in peak systolic velocity (PSV) in intracranial and extracranial arteries assessed by ultrasound from baseline to within 72 hours after CAS.
Time frame: From baseline to within 72 hours after CAS
Incidence of Restenosis Assessed by Computed Tomographic Angiography (CTA) Within 72 Hours After CAS
Proportion of participants with restenosis assessed by computed tomographic angiography (CTA) within 72 hours after CAS.
Time frame: Within 72 hours after CAS
Number of New Cerebral Lesions on DWI Within 48 Hours After CAS
Zhao Wenbo
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of new cerebral lesions detected on brain diffusion-weighted imaging (DWI) within 48 hours after CAS.
Time frame: Within 48 hours after CAS
Incidence of acute myocardial infarction within 1 month after CAS.
Proportion of participants with acute myocardial infarction within 1 month after CAS
Time frame: within 1 month after CAS
Incidence of All-Cause Death Within 1 Month After CAS
Proportion of participants who died from any cause within 1 month after CAS.
Time frame: within 1 month after CAS
Volume of New Cerebral Lesions on DWI Within 48 Hours After CAS
Volume of new cerebral lesions detected on brain diffusion-weighted imaging (DWI) within 48 hours after CAS, measured in mm³.
Time frame: Within 48 hours after CAS.
Change in Heart Rate Variability (HRV) Within 72 Hours After CAS
Change in heart rate variability (HRV) within 72 hours after CAS.
Time frame: Within 72 hours after CAS.
Change in Blood Pressure (BP) Within 72 Hours After CAS
Change in blood pressure (BP) within 72 hours after CAS.
Time frame: Within 72 hours after CAS.
Change in Intracranial Pressure (ICP) Within 72 Hours After CAS
Change in intracranial pressure (ICP) within 72 hours after CAS.
Time frame: Within 72 hours after CAS.
Change in Cerebral Perfusion Pressure (CPP) Within 72 Hours After CAS
Change in cerebral perfusion pressure (CPP) within 72 hours after CAS.
Time frame: Within 72 hours after CAS.