Clinical trial NCT02966418: Hypoxic Preconditioning on Patients
Official title: The Effects of Intermittent Whole-body Hypoxic Preconditioning on Patients With Carotid Artery Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxic Preconditioning
Carotid Artery Stenosis
Ischemic Cerebrovascular Disease
Keywords: Hypoxic preconditioning
Carotid artery stenosis
Ischemic cerebrovascular disease
Lead sponsor: Tianjin Huanhu Hospital
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to study the effects of intermittent whole-body hypoxic preconditioning on patients with carotid artery stenosis.


Eligibility criteria: 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.

Primary outcomes:
measure: Respiratory rate
timeFrame: Before, during and 5 min after the intervention.
measure: Heart rate
timeFrame: Before, during and 5 min after the intervention.
measure: Systolic blood pressure
timeFrame: Before, during and 5 min after the intervention.
measure: Arterial blood oxygen saturation
timeFrame: Before, during and 5 min after the intervention.
measure: Hemoglobin content
timeFrame: On admission, and at the 1st day after surgery.
measure: Hypoxia inducible factor-1α
timeFrame: On admission, and at the 1st day after surgery.
measure: Erythropoietin
timeFrame: On admission, and at the 1st day after surgery.
measure: Vascular endothelial growth factor
timeFrame: On admission, and at the 1st day after surgery.
measure: Neuron-specific enolase
timeFrame: On admission, and at the 1st day after surgery.
measure: S100β protein
timeFrame: On admission, and at the 1st day after surgery.
measure: Brain-derived neurotrophic factor
timeFrame: On admission, and at the 1st day after surgery.
Secondary outcomes:
measure: Serum aspartate transaminase
timeFrame: On admission, and at the 1st day after surgery.
measure: Serum alanine aminotransferase
timeFrame: On admission, and at the 1st day after surgery.
measure: Serum creatinine
timeFrame: On admission, and at the 1st day after surgery.
measure: Blood urea nitrogen
timeFrame: On admission, and at the 1st day after surgery.
measure: The incidence of adverse events
timeFrame: During the intervention.
measure: Average length of hospital stay
timeFrame: Through study completion, an average of 3 months.
measure: Postoperative complications
timeFrame: Through study completion, an average of 3 months.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin HuanHu Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Huanhu Hospital
name: Hua Yan, Doctor
role: STUDY_CHAIR
References: