The Effects of Intermittent Whole-body Hypoxic Preconditioning on Patients With Carotid Artery Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Respiratory rate
研究概览
简要总结
The purpose of this study is to study the effects of intermittent whole-body hypoxic preconditioning on patients with carotid artery stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed written consent from the patient.
- •Han nationality, age >18 years.
- •Carotid artery stenosis on at least one side, measuring more than 70% by ultrasonic detection and requiring carotid artery stenting or a carotid endarterectomy.
- •Long-term residence at an altitude of <100 m (the altitude of Tianjin is 2-5 m).
- •Not having been to an altitude ≥1500 m in two years.
排除标准
- •Planned vessel sacrifice as the primary modality for ischemic cerebrovascular treatment.
- •Systemic blood disease before intervention.
- •Regular physical activity exercise: frequency >1 time/week, duration >20 min.
- •History of brain disease or history of stroke or transient ischemic attack within the previous six months.
- •History of heart, liver, kidney or lung disease.
- •History of hypertension and poor blood pressure control, with blood pressure >160/90 mmHg.
结局指标
主要结局
Respiratory rate
时间窗: Before, during and 5 min after the intervention.
Heart rate
时间窗: Before, during and 5 min after the intervention.
Hypoxia inducible factor-1α
时间窗: On admission, and at the 1st day after surgery.
Erythropoietin
时间窗: On admission, and at the 1st day after surgery.
Vascular endothelial growth factor
时间窗: On admission, and at the 1st day after surgery.
Neuron-specific enolase
时间窗: On admission, and at the 1st day after surgery.
Systolic blood pressure
时间窗: Before, during and 5 min after the intervention.
Arterial blood oxygen saturation
时间窗: Before, during and 5 min after the intervention.
Hemoglobin content
时间窗: On admission, and at the 1st day after surgery.
S100β protein
时间窗: On admission, and at the 1st day after surgery.
Brain-derived neurotrophic factor
时间窗: On admission, and at the 1st day after surgery.
次要结局
- The incidence of adverse events(During the intervention.)
- Serum aspartate transaminase(On admission, and at the 1st day after surgery.)
- Serum alanine aminotransferase(On admission, and at the 1st day after surgery.)
- Average length of hospital stay(Through study completion, an average of 3 months.)
- Postoperative complications(Through study completion, an average of 3 months.)
- Serum creatinine(On admission, and at the 1st day after surgery.)
- Blood urea nitrogen(On admission, and at the 1st day after surgery.)
研究者
Hua Yan
Director
Tianjin Huanhu Hospital