Hypoxic Preconditioning on Patients

The Effects of Intermittent Whole-body Hypoxic Preconditioning on Patients With Carotid Artery Stenosis

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

Study Overview

• Status: Completed
• Conditions: Carotid Artery Stenosis; Ischemic Cerebrovascular Disease; Hypoxic Preconditioning
• Intervention / Treatment: Procedure: Mild Hypoxia Preconditioning; Procedure: Sham preconditioning

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300350
      • Tianjin Huanhu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Sham Comparator: Sham preconditioning; Patients will be treated with sham preconditioning (oxygen concentration: 21％) before surgery.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.
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.
Brain-derived neurotrophic factor	On admission, and at the 1st day after surgery.

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum aspartate transaminase	On admission, and at the 1st day after surgery.
Serum alanine aminotransferase	On admission, and at the 1st day after surgery.
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.

Collaborators and Investigators

• Sponsor: Hua Yan
• Investigators: Study Chair: Hua Yan, Doctor, Tianjin Huanhu Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 6, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Ischemic cerebrovascular disease; Carotid artery stenosis; Hypoxic preconditioning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Signs and Symptoms, Respiratory; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic; Hypoxia; Cerebrovascular Disorders
• Other Study ID Numbers: JH2016-17