Hypoxic PreconditioningNCT02966418
Hypoxic Preconditioning on Patients
A study testing Mild Hypoxia Preconditioning in people with Hypoxic Preconditioning and Carotid Artery Stenosis, run by Hua Yan at 1 site in China.
Trial summary
The purpose of this study is to study the effects of intermittent whole-body hypoxic preconditioning on patients with carotid artery stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxic Preconditioning, Carotid Artery Stenosis, Ischemic Cerebrovascular Disease
- What is being tested?
- Mild Hypoxia Preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Intermittent Whole-body Hypoxic Preconditioning on Patients With Carotid Artery Stenosis
The purpose of this study is to study the effects of intermittent whole-body hypoxic preconditioning on patients with carotid artery stenosis.
- Being tested
- Mild Hypoxia Preconditioning, Sham preconditioning
- Keywords
- Hypoxic preconditioning, Carotid artery stenosis, Ischemic cerebrovascular disease
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild Hypoxia PreconditioningProcedure or surgery
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 preconditioningProcedure or surgery
Patients will be treated with sham preconditioning (oxygen concentration: 21％) ×7 days，twice a day in the morning and in the afternoon before surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Mild Hypoxia Preconditioning |
| Sham preconditioning | Sham comparator | Patients will be treated with sham preconditioning (oxygen concentration: 21％) before surgery. Receives: Procedure: Sham preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate
Measured: Before, during and 5 min after the intervention.
Heart rate
Measured: Before, during and 5 min after the intervention.
Systolic blood pressure
Measured: Before, during and 5 min after the intervention.
Arterial blood oxygen saturation
Measured: Before, during and 5 min after the intervention.
Hemoglobin content
Measured: On admission, and at the 1st day after surgery.
Hypoxia inducible factor-1α
Measured: On admission, and at the 1st day after surgery.
Erythropoietin
Measured: On admission, and at the 1st day after surgery.
Vascular endothelial growth factor
Measured: On admission, and at the 1st day after surgery.
Neuron-specific enolase
Measured: On admission, and at the 1st day after surgery.
S100β protein
Measured: On admission, and at the 1st day after surgery.
Brain-derived neurotrophic factor
Measured: On admission, and at the 1st day after surgery.
Secondary outcomes (7)
Serum aspartate transaminase
Measured: On admission, and at the 1st day after surgery.
Serum alanine aminotransferase
Measured: On admission, and at the 1st day after surgery.
Serum creatinine
Measured: On admission, and at the 1st day after surgery.
Blood urea nitrogen
Measured: On admission, and at the 1st day after surgery.
The incidence of adverse events
Measured: During the intervention.
Average length of hospital stay
Measured: Through study completion, an average of 3 months.
Postoperative complications
Measured: Through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic PreconditioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Yan, Tianjin Huanhu Hospital
- Investigators
- Hua Yan, Doctor, Study chair, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966418
- Sponsor's protocol ID
- JH2016-17
- Status last verified
- Feb 2018
- First submitted
- 6 Nov 2016
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intermittent Whole-body Hypoxic Preconditioning on Patients With Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT02966418
- Acronym / sponsor ID
- JH2016-17
- Keywords
- Hypoxic preconditioning, Carotid artery stenosis, Ischemic cerebrovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hua YanUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the effects of intermittent whole-body hypoxic preconditioning on patients with carotid artery stenosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild hypoxia preconditioning | Active comparator | Procedure: Mild Hypoxia PreconditioningPatients will be treated with mild hypoxia (Note: The oxygen concentration decreased from 20% to 18%, and keeping at 18%) before surgery. |
| Sham preconditioning | Sham comparator | Procedure: Sham preconditioningPatients will be treated with sham preconditioning (oxygen concentration: 21％) before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mild Hypoxia PreconditioningPatients 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. | Procedure or surgery | Mild hypoxia preconditioning |
| Sham preconditioningPatients will be treated with sham preconditioning (oxygen concentration: 21％) ×7 days，twice a day in the morning and in the afternoon before surgery. | Procedure or surgery | Sham preconditioning |
Primary outcome
Respiratory rate
Time frame: Before, during and 5 min after the intervention.
Heart rate
Time frame: Before, during and 5 min after the intervention.
Systolic blood pressure
Time frame: Before, during and 5 min after the intervention.
Arterial blood oxygen saturation
Time frame: Before, during and 5 min after the intervention.
Hemoglobin content
Time frame: On admission, and at the 1st day after surgery.
Hypoxia inducible factor-1α
Time frame: On admission, and at the 1st day after surgery.
Erythropoietin
Time frame: On admission, and at the 1st day after surgery.
Vascular endothelial growth factor
Time frame: On admission, and at the 1st day after surgery.
Neuron-specific enolase
Time frame: On admission, and at the 1st day after surgery.
S100β protein
Time frame: On admission, and at the 1st day after surgery.
Brain-derived neurotrophic factor
Time frame: On admission, and at the 1st day after surgery.
7 secondary outcomes
Serum aspartate transaminase
Time frame: On admission, and at the 1st day after surgery.
Serum alanine aminotransferase
Time frame: On admission, and at the 1st day after surgery.
Serum creatinine
Time frame: On admission, and at the 1st day after surgery.
Blood urea nitrogen
Time frame: On admission, and at the 1st day after surgery.
The incidence of adverse events
Time frame: During the intervention.
Average length of hospital stay
Time frame: Through study completion, an average of 3 months.
Postoperative complications
Time frame: Through study completion, an average of 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hua Yan, Doctor study chair
Tianjin Huanhu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mild Hypoxia Preconditioning in people with Hypoxic Preconditioning and Carotid Artery Stenosis, run by Hua Yan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate (time frame: Before, during and 5 min after the intervention.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.