Carotid Artery Stenosis, Hypoxic Preconditioning, Ischemic Cerebrovascular Disease
Conditions
Keywords
Hypoxic preconditioning, Carotid artery stenosis, Ischemic cerebrovascular disease
Brief summary
The purpose of this study is to study the effects of intermittent whole-body hypoxic preconditioning on patients with carotid artery stenosis.
Interventions
PROCEDUREMild Hypoxia Preconditioning
Patients will be treated with mild hypoxia ( Note: The oxygen concentration decreased from 20% to 18%, and keeping at 18%)×7 days，twice a day in the morning and in the afternoon before surgery.
PROCEDURESham preconditioning
Patients will be treated with sham preconditioning (oxygen concentration: 21％) ×7 days，twice a day in the morning and in the afternoon before surgery.
Sponsors
Hua Yan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed written consent from the patient. 2. Han nationality, age \>18 years. 3. Carotid artery stenosis on at least one side, measuring more than 70% by ultrasonic detection and requiring carotid artery stenting or a carotid endarterectomy. 4. Long-term residence at an altitude of \<100 m (the altitude of Tianjin is 2-5 m). 5. Not having been to an altitude ≥1500 m in two years.
Exclusion criteria
1. Planned vessel sacrifice as the primary modality for ischemic cerebrovascular treatment. 2. Systemic blood disease before intervention. 3. Regular physical activity exercise: frequency \>1 time/week, duration \>20 min. 4. History of brain disease or history of stroke or transient ischemic attack within the previous six months. 5. History of heart, liver, kidney or lung disease. 6. History of hypertension and poor blood pressure control, with blood pressure \>160/90 mmHg. 7. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain-derived neurotrophic factor | On admission, and at the 1st day after surgery. |
| Arterial blood oxygen saturation | Before, during and 5 min after the intervention. |
| Hemoglobin content | On admission, and at the 1st day after surgery. |
| Hypoxia inducible factor-1α | On admission, and at the 1st day after surgery. |
| Erythropoietin | On admission, and at the 1st day after surgery. |
| Vascular endothelial growth factor | On admission, and at the 1st day after surgery. |
| Neuron-specific enolase | On admission, and at the 1st day after surgery. |
| S100β protein | On admission, and at the 1st day after surgery. |
| Respiratory rate | Before, during and 5 min after the intervention. |
| Heart rate | Before, during and 5 min after the intervention. |
| Systolic blood pressure | Before, during and 5 min after the intervention. |
Secondary
| Measure | Time frame |
|---|---|
| Serum creatinine | On admission, and at the 1st day after surgery. |
| Blood urea nitrogen | On admission, and at the 1st day after surgery. |
| The incidence of adverse events | During the intervention. |
| Average length of hospital stay | Through study completion, an average of 3 months. |
| Postoperative complications | Through study completion, an average of 3 months. |
| Serum aspartate transaminase | On admission, and at the 1st day after surgery. |
| Serum alanine aminotransferase | On admission, and at the 1st day after surgery. |
Countries
China
Outcome results
None listed