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The Efficacy and Safety of Normobaric Oxygen on Chronic Cerebral Circulation Insufficiency

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ClinicalTrials.gov Identifier: NCT03745092
Recruitment Status : Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ran Meng, Capital Medical University

Brief Summary:
Chronic cerebral circulation insufficiency (CCCI) is viewed as an alarming state induced by long-term reduction in cerebral perfusion, which is associated with neurological deficits and high risk of stroke occurrence or recurrence. CCCI accounts for a large proportion in both outpatient and inpatient subjects with cerebrovascular disease, while the treatment of CCCI remains a formidable challenge to clinicians. Normobaric oxygen (NBO) is an adjuvant hyper-oxygenation intervention supplied with one atmosphere pressure (1ATA=101.325kPa). A plethora of studies have demonstrated the efficacy of NBO on the penumbra in acute stroke. NBO has been shown to increase oxygen pressure, raise intracranial blood flow, protect blood-brain barrier and enhance neuro-protective effects. As the similar underlying mechanisms shared by the penumbra in stroke and the ischemic-hypoxic brain tissues in CCCI, the investigators speculate that NBO may serve as a promising therapeutic strategy for attenuating short-term symptoms or improving long-term clinical outcomes amongst patients with CCCI. Due to the scant research exploring the efficacy and safety of NBO for treating CCCI so far, the clinical studies are warranted to verify this hypothesis urgently.

Condition or disease Intervention/treatment Phase
Normobaric Oxygen Cerebral Ischemia Device: normobaric oxygen Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Normobaric Oxygen on Chronic Cerebral Circulation Insufficiency
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Normobaric oxygen group
Patients who are diagnosed as chronic cerebral circulation insufficiency will be recruited into the normobaric oxygen group to receive NBO (5-8L/min, via nasal cannula or face mask) 1 hour per time, 3 times per day for 6 months, and the other routine medical therapy.
Device: normobaric oxygen
Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by nasal cannula or facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).

No Intervention: Control group
Patients in the control group will undergo only routine treatments without NBO for the same period of time.



Primary Outcome Measures :
  1. White matter lesion scale (Scheltens scales) [ Time Frame: 6 months ]
    The Scheltens scale has a range from 0-84, where scores 0-6 can be given in periventricular regions, 0-24 in the deep WM, 0-30 in the basal ganglia, and 0-24 in infratentorial regions.

  2. Patient Global Impression of Change (PGIC) scale [ Time Frame: 2 week ]
    The PGIC is a self-evaluation of the patient's overall change since the start of the study according to a 7-point Likert scale (1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse).


Secondary Outcome Measures :
  1. Incidence of ischemic events [ Time Frame: 6 months ]
    The incidence of ischemic events (including recurrent ischemic stroke, TIA, TGA, etc.) after initiation of the intervention,

  2. headache visual analog scale (Headache VAS) [ Time Frame: 1, 3 and 6 months ]
    Visual analog scale (VAS) is a method of measuring a subjective construct believed to exist along a continuum. VAS typically takes the form of a straight line of a specific length, usually 100 mm, with extreme descriptors at either end. Individuals rate the characteristic or attitude of interest by placing a mark at a point somewhere along the line that represents their subjective experience. The range of VAS is from 0 (no headache) to 10 (worst possible pain).

  3. European evaluation of vertigo scale (EEV) [ Time Frame: 1, 3 and 6 months ]
    The European Evaluation of Vertigo scale (EEV) is a physician-administered questionnaire that consists of five equally weighted items scored from 0 to 4 on a categorical five-point scale. The following five items are considered : "Illusion of Movement", "Duration of the Illusion", "Motion Intolerance", "Neurovegetative Signs", and "Instability".

  4. modified Rankin scale (mRS) [ Time Frame: 1, 3 and 6 months ]
    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.

  5. Barthel index (BI) [ Time Frame: 1, 3 and 6 months ]
    The Barthel scale (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). BI consists of ten items (total 100 scores) describing ADL and mobility. Each performance item is rated on this scale with a given number of points assigned to each level or ranking. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.

  6. Incidence of complications [ Time Frame: 1, 3 and 6 months ]
    Complications are used to determine the safety of normobaric oxygen on chronic cerebral circulation insufficiency patients, including abnormal symptoms (such as chest pain, dyspnea, insomnia, etc.), respiratory abnormality (infection, respiratory alkalosis, respiratory acidosis, etc.) and cardiovascular diseases (arrhythmia).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The symptoms of chronic cerebral circulation insufficiency maintain more than two months;
  2. Chronic cerebral circulation insufficiency should be caused by intracranial artery stenosis, cerebral venous system stenosis and cardiogenic cerebral circulation insufficiency;
  3. The informed consents should be obtained from the patients before initiating any study-specific procedures.

Exclusion Criteria:

  1. Patients undergoing thrombolysis prior to enrollment in 24 hours;
  2. Patients have been performed endovascular treatment;
  3. Patients are under life-threatening condition;
  4. Accompanied by other severe diseases;
  5. Cerebral hemorrhage history;
  6. Arterial aneurysm and malformation;
  7. Afflicted by respiratory system disease;
  8. Pregnant and breast feeding women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745092


Contacts
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Contact: Ran H Meng, professor +86-10-83199280 ext +861083199280 ranmeng2011@pku.org.cn
Contact: Ran H Meng, professor +861083199280 ext +861083199280 ranmeng2011@pku.org.cn

Locations
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China
Xuanwu Hospital, Captial Medical University Not yet recruiting
Beijing, China, 100053
Contact: Ran Meng, Professor    +86-10-83199280    ranmeng2011@pku.org.cn   
Principal Investigator: Jiayue Ding         
Principal Investigator: Chaobo Bai         
Principal Investigator: Da Zhou         
Principal Investigator: Liqun Pan         
Principal Investigator: Jingyuan Ya         
Principal Investigator: Cheng Liu         
Principal Investigator: Kexin Jin         
Principal Investigator: Zhongao Wang         
Principal Investigator: Jingwei Guan         
Principal Investigator: Jingkun Sun         
Principal Investigator: Siying Song         
Sponsors and Collaborators
Capital Medical University

Publications of Results:

Other Publications:
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Responsible Party: Ran Meng, Principal investigator, Capital Medical University
ClinicalTrials.gov Identifier: NCT03745092     History of Changes
Other Study ID Numbers: NBO-CCCI
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: including the number of enrolled cases, the primary outcomes and the second outcomes.
Supporting Materials: Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ran Meng, Capital Medical University:
normobaric oxygen
chronic cerebral ischemia

Additional relevant MeSH terms:
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Ischemia
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke