Back to resultsHypoxic Preconditioning on Patients
Primary Purpose
Hypoxic Preconditioning, Carotid Artery Stenosis, Ischemic Cerebrovascular Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mild Hypoxia Preconditioning
Sham preconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxic Preconditioning focused on measuring Hypoxic preconditioning, Carotid artery stenosis, Ischemic cerebrovascular disease
Eligibility Criteria
Inclusion Criteria:
- Informed written consent from the patient.
- Han nationality, age >18 years.
- Carotid artery stenosis on at least one side, measuring more than 70% by ultrasonic detection and requiring carotid artery stenting or a carotid endarterectomy.
- Long-term residence at an altitude of <100 m (the altitude of Tianjin is 2-5 m).
- Not having been to an altitude ≥1500 m in two years.
Exclusion Criteria:
- Planned vessel sacrifice as the primary modality for ischemic cerebrovascular treatment.
- Systemic blood disease before intervention.
- Regular physical activity exercise: frequency >1 time/week, duration >20 min.
- History of brain disease or history of stroke or transient ischemic attack within the previous six months.
- History of heart, liver, kidney or lung disease.
- History of hypertension and poor blood pressure control, with blood pressure >160/90 mmHg.
- Pregnancy.
Sites / Locations
- Tianjin HuanHu Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Mild hypoxia preconditioning
Sham preconditioning
Arm Description
Patients will be treated with mild hypoxia (Note: The oxygen concentration decreased from 20% to 18%, and keeping at 18%) before surgery.
Patients will be treated with sham preconditioning (oxygen concentration: 21％) before surgery.
Outcomes
Primary Outcome Measures
Respiratory rate
Heart rate
Systolic blood pressure
Arterial blood oxygen saturation
Hemoglobin content
Hypoxia inducible factor-1α
Erythropoietin
Vascular endothelial growth factor
Neuron-specific enolase
S100β protein
Brain-derived neurotrophic factor
Secondary Outcome Measures
Serum aspartate transaminase
Serum alanine aminotransferase
Serum creatinine
Blood urea nitrogen
The incidence of adverse events
Average length of hospital stay
Postoperative complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02966418
Brief Title
Hypoxic Preconditioning on Patients
Official Title
The Effects of Intermittent Whole-body Hypoxic Preconditioning on Patients With Carotid Artery Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hua Yan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to study the effects of intermittent whole-body hypoxic preconditioning on patients with carotid artery stenosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic Preconditioning, Carotid Artery Stenosis, Ischemic Cerebrovascular Disease
Keywords
Hypoxic preconditioning, Carotid artery stenosis, Ischemic cerebrovascular disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild hypoxia preconditioning
Arm Type
Active Comparator
Arm Description
Patients will be treated with mild hypoxia (Note: The oxygen concentration decreased from 20% to 18%, and keeping at 18%) before surgery.
Arm Title
Sham preconditioning
Arm Type
Sham Comparator
Arm Description
Patients will be treated with sham preconditioning (oxygen concentration: 21％) before surgery.
Intervention Type
Procedure
Intervention Name(s)
Mild Hypoxia Preconditioning
Intervention Description
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
Intervention Name(s)
Sham preconditioning
Intervention Description
Patients will be treated with sham preconditioning (oxygen concentration: 21％) ×7 days，twice a day in the morning and in the afternoon before surgery.
Primary Outcome Measure Information:
Title
Respiratory rate
Time Frame
Before, during and 5 min after the intervention.
Title
Heart rate
Time Frame
Before, during and 5 min after the intervention.
Title
Systolic blood pressure
Time Frame
Before, during and 5 min after the intervention.
Title
Arterial blood oxygen saturation
Time Frame
Before, during and 5 min after the intervention.
Title
Hemoglobin content
Time Frame
On admission, and at the 1st day after surgery.
Title
Hypoxia inducible factor-1α
Time Frame
On admission, and at the 1st day after surgery.
Title
Erythropoietin
Time Frame
On admission, and at the 1st day after surgery.
Title
Vascular endothelial growth factor
Time Frame
On admission, and at the 1st day after surgery.
Title
Neuron-specific enolase
Time Frame
On admission, and at the 1st day after surgery.
Title
S100β protein
Time Frame
On admission, and at the 1st day after surgery.
Title
Brain-derived neurotrophic factor
Time Frame
On admission, and at the 1st day after surgery.
Secondary Outcome Measure Information:
Title
Serum aspartate transaminase
Time Frame
On admission, and at the 1st day after surgery.
Title
Serum alanine aminotransferase
Time Frame
On admission, and at the 1st day after surgery.
Title
Serum creatinine
Time Frame
On admission, and at the 1st day after surgery.
Title
Blood urea nitrogen
Time Frame
On admission, and at the 1st day after surgery.
Title
The incidence of adverse events
Time Frame
During the intervention.
Title
Average length of hospital stay
Time Frame
Through study completion, an average of 3 months.
Title
Postoperative complications
Time Frame
Through study completion, an average of 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed written consent from the patient.
Han nationality, age >18 years.
Carotid artery stenosis on at least one side, measuring more than 70% by ultrasonic detection and requiring carotid artery stenting or a carotid endarterectomy.
Long-term residence at an altitude of <100 m (the altitude of Tianjin is 2-5 m).
Not having been to an altitude ≥1500 m in two years.
Exclusion Criteria:
Planned vessel sacrifice as the primary modality for ischemic cerebrovascular treatment.
Systemic blood disease before intervention.
Regular physical activity exercise: frequency >1 time/week, duration >20 min.
History of brain disease or history of stroke or transient ischemic attack within the previous six months.
History of heart, liver, kidney or lung disease.
History of hypertension and poor blood pressure control, with blood pressure >160/90 mmHg.
Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Yan, Doctor
Organizational Affiliation
Tianjin Huanhu Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin HuanHu Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300350
Country
China
12. IPD Sharing Statement
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