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Completed

NCT Number: NCT02966418

Hypoxic Preconditioning on Patients

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

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Key information

Conditions

Hypoxic Preconditioning Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Artery Stenosis Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Ischemic Cerebrovascular Disease Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin HuanHu Hospital

Tianjin, Tianjin Municipality, 300350, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mild Hypoxia Preconditioning

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

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.

Primary outcomes

  1. Respiratory rate

    Time frame: Before, during and 5 min after the intervention.

  2. Heart rate

    Time frame: Before, during and 5 min after the intervention.

  3. Systolic blood pressure

    Time frame: Before, during and 5 min after the intervention.

  4. Arterial blood oxygen saturation

    Time frame: Before, during and 5 min after the intervention.

  5. Hemoglobin content

    Time frame: On admission, and at the 1st day after surgery.

  6. Hypoxia inducible factor-1α

    Time frame: On admission, and at the 1st day after surgery.

  7. Erythropoietin

    Time frame: On admission, and at the 1st day after surgery.

  8. Vascular endothelial growth factor

    Time frame: On admission, and at the 1st day after surgery.

  9. Neuron-specific enolase

    Time frame: On admission, and at the 1st day after surgery.

  10. S100β protein

    Time frame: On admission, and at the 1st day after surgery.

  11. Brain-derived neurotrophic factor

    Time frame: On admission, and at the 1st day after surgery.

Secondary outcomes

  1. Serum aspartate transaminase

    Time frame: On admission, and at the 1st day after surgery.

  2. Serum alanine aminotransferase

    Time frame: On admission, and at the 1st day after surgery.

  3. Serum creatinine

    Time frame: On admission, and at the 1st day after surgery.

  4. Blood urea nitrogen

    Time frame: On admission, and at the 1st day after surgery.

  5. The incidence of adverse events

    Time frame: During the intervention.

  6. Average length of hospital stay

    Time frame: Through study completion, an average of 3 months.

  7. Postoperative complications

    Time frame: Through study completion, an average of 3 months.

Sponsors and collaborators

Lead sponsor

Hua Yan

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2016
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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