Clinical trial NCT06702644: Safety and Efficacy of Remote Ischemic Conditioning in Patients with Chronic Internal Carotid Artery Occlusion Receiving Hybird Surgery: a Pilot, Randomized Controlled Trial
Official title: Safety and Efficacy of Remote Ischemic Conditioning in Patients with Chronic Internal Carotid Artery Occlusion Receiving Hybird Surgery: a Pilot, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carotid Artery Occlusion
Keywords: RIC
remote ischemic conditioning
carotid artery occlusion
hybird surgery
interventional surgery
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with new Diffusion Weighted Imaging (DWI) - positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
timeFrame: 6 days
Secondary outcomes:
measure: The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
timeFrame: 6 days
measure: The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
timeFrame: 6 days
measure: Number of patients with cerebrovascular events, cardiovascular events or death
timeFrame: 90±7 days
measure: Proportion of patients with any side effects of RIC treatment.
timeFrame: 6 days
measure: Proportion of patients with any adverse events（including serious adverse events)
timeFrame: 90±7 days
Other outcomes:
Locations:
Study officials:
affiliation: Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
name: Yi Yang, MD, PhD
role: STUDY_CHAIR
References: