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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02966418
Other study ID # JH2016-17
Secondary ID
Status Completed
Phase N/A
First received November 6, 2016
Last updated February 27, 2018
Start date January 2017
Est. completion date December 2017

Study information

Verified date February 2018
Source Tianjin Huanhu Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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 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.

Locations

Country Name City State
China Tianjin HuanHu Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Hua Yan

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory rate Before, during and 5 min after the intervention.
Primary Heart rate Before, during and 5 min after the intervention.
Primary Systolic blood pressure Before, during and 5 min after the intervention.
Primary Arterial blood oxygen saturation Before, during and 5 min after the intervention.
Primary Hemoglobin content On admission, and at the 1st day after surgery.
Primary Hypoxia inducible factor-1a On admission, and at the 1st day after surgery.
Primary Erythropoietin On admission, and at the 1st day after surgery.
Primary Vascular endothelial growth factor On admission, and at the 1st day after surgery.
Primary Neuron-specific enolase On admission, and at the 1st day after surgery.
Primary S100ß protein On admission, and at the 1st day after surgery.
Primary Brain-derived neurotrophic factor On admission, and at the 1st day after surgery.
Secondary Serum aspartate transaminase On admission, and at the 1st day after surgery.
Secondary Serum alanine aminotransferase On admission, and at the 1st day after surgery.
Secondary Serum creatinine On admission, and at the 1st day after surgery.
Secondary Blood urea nitrogen On admission, and at the 1st day after surgery.
Secondary The incidence of adverse events During the intervention.
Secondary Average length of hospital stay Through study completion, an average of 3 months.
Secondary Postoperative complications Through study completion, an average of 3 months.
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