Hypoxic Preconditioning on Patients

Carotid Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966418
• Other study ID #: JH2016-17
• 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
• 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.

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Cerebrovascular Disorders
• Constriction, Pathologic
• Hypoxia
• Hypoxic Preconditioning
• Ischemic Cerebrovascular Disease

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.