Safety and Efficacy of Remote Ischemic Conditioning in Patients with Chronic Internal Carotid Artery Occlusion Receiving Hybird Surgery: a Pilot, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carotid Artery Occlusion
- Sponsor
- Yi Yang
- Enrollment
- 60
- Primary Endpoint
- Proportion of patients with new Diffusion Weighted Imaging (DWI) - positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Yi Yang
Vice president of The First Hospital of Jilin University
The First Hospital of Jilin University
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
Outcomes
Primary Outcomes
Proportion of patients with new Diffusion Weighted Imaging (DWI) - positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Time Frame: 6 days
Patients will undergo magnetic resonance imaging (including DWI) at baseline and 6 days after randomization.
Secondary Outcomes
- The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.(6 days)
- The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.(6 days)
- Number of patients with cerebrovascular events, cardiovascular events or death(90±7 days)
- Proportion of patients with any side effects of RIC treatment.(6 days)
- Proportion of patients with any adverse events（including serious adverse events)(90±7 days)