Hypoxic Preconditioning on Patients

Hua Yan

Status: Completed

Conditions: Ischemic Cerebrovascular Disease; Carotid Artery Stenosis; Hypoxic Preconditioning

Treatments: Procedure: Mild Hypoxia Preconditioning; Procedure: Sham preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02966418

JH2016-17

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Mild hypoxia preconditioning

Active Comparator group

Description:

Patients will be treated with mild hypoxia (Note: The oxygen concentration decreased from 20% to 18%, and keeping at 18%) before surgery.

Treatment:

Procedure: Mild Hypoxia Preconditioning

Sham preconditioning

Sham Comparator group

Description:

Patients will be treated with sham preconditioning (oxygen concentration: 21％) before surgery.

Treatment:

Procedure: Sham preconditioning