NCT02966418

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

November 6, 2016

Last Update Submit

February 27, 2018

Conditions

Hypoxic PreconditioningCarotid Artery StenosisIschemic Cerebrovascular Disease

Keywords

Hypoxic preconditioningCarotid artery stenosisIschemic cerebrovascular disease

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (7)

  • 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.

  • +2 more secondary outcomes

Study Arms (2)

Mild hypoxia preconditioning

ACTIVE COMPARATOR

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

Sham preconditioning

SHAM COMPARATOR

Patients will be treated with sham preconditioning (oxygen concentration: 21％) before surgery.

Procedure: Sham preconditioning

Interventions

Mild Hypoxia PreconditioningPROCEDURE

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.

Mild hypoxia preconditioning
Sham preconditioningPROCEDURE

Patients will be treated with sham preconditioning (oxygen concentration: 21％) ×7 days，twice a day in the morning and in the afternoon before surgery.

Sham preconditioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin HuanHu Hospital

Tianjin, Tianjin Municipality, 300350, China

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hua Yan, Doctor

    Tianjin Huanhu Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 6, 2016

First Posted

November 17, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 1, 2018

Record last verified: 2018-02

Locations

CN(1)