Hypoxic Preconditioning on Patients

Not Applicable

Completed

• Conditions: Hypoxic Preconditioning; Carotid Artery Stenosis; Ischemic Cerebrovascular Disease
• Interventions: Procedure: Mild Hypoxia Preconditioning; Procedure: Sham preconditioning

• Registration Number: NCT02966418
• Lead Sponsor: Hua Yan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-06
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-17
• Study Start: 2017-01
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild hypoxia preconditioning	Mild Hypoxia Preconditioning	Patients will be treated with mild hypoxia (Note: The oxygen concentration decreased from 20% to 18%, and keeping at 18%) before surgery.
Sham preconditioning	Sham preconditioning	Patients will be treated with sham preconditioning (oxygen concentration: 21％) before surgery.

Primary Outcome Measures

Name	Time	Method
Respiratory rate	Before, during and 5 min after the intervention.
Heart rate	Before, during and 5 min after the intervention.
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.
Systolic blood pressure	Before, during and 5 min after the intervention.
Arterial blood oxygen saturation	Before, during and 5 min after the intervention.
Hemoglobin content	On admission, and at the 1st day after surgery.
S100β protein	On admission, and at the 1st day after surgery.
Brain-derived neurotrophic factor	On admission, and at the 1st day after surgery.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tianjin HuanHu Hospital; 🇨🇳 Tianjin, Tianjin, China