Hypoxic Preconditioning on Patients

NCT ID: NCT02966418

Last Updated: 2018-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hypoxic Preconditioning Carotid Artery Stenosis Ischemic Cerebrovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Mild Hypoxia Preconditioning

Intervention Type PROCEDURE

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.

Sham preconditioning

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

Group Type SHAM_COMPARATOR

Sham preconditioning

Intervention Type PROCEDURE

Patients will be treated with sham preconditioning (oxygen concentration: 21%) ×7 days,twice a day in the morning and in the afternoon before surgery.

Interventions

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Mild 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.

Intervention Type PROCEDURE

Sham 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hua Yan

OTHER

Sponsor Role lead

Responsible Party

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Hua Yan

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hua Yan, Doctor

Role: STUDY_CHAIR

Tianjin Huanhu Hospital

Locations

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Tianjin HuanHu Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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JH2016-17

Identifier Type: -

Identifier Source: org_study_id

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