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Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial

Primary Purpose

Carotid Stenosis, Cognitive Impairment, Hyperbaric Oxygen Therapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyperbaric oxygen therapy
Standard medical treatment
Risk factor management
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Stenosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age from 18 to 75 years Ischemic stroke or transient ischemic attack (TIA) occurred within 30 days before endovascular stent treatment National Institute of Health stroke scale (NIHSS) ≤3 Culprit vessel was the common carotid artery or extracranial internal carotid artery, involving or not involving the external carotid artery The degree of culprit arterial stenosis is 70-99 % ; based on Digital subtraction angiography (DSA) (According to North American Symptomatic Carotid Endarterectomy Trial (NASCET) method) The diameter of the target vessel between 4.0 mm - 9.0 mm Mini-mental State Examination (MMSE) score : education level-middle school ≤ 24; education level-high school ≤ 20 ; education level-college ≤ 17 Baseline modified Rankin Scale (mRS) score ≤ 3 Patient understands the purpose and requirements of the study, and has provided informed consent Exclusion Criteria: Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion Serious perioperative complications affecting subsequent hyperbaric oxygen therapy (such as cerebral hemorrhage, disabling stroke, etc.) Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 12 months Hemorrhagic transformation after ischemic stroke within 60 days before enrollment Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, Moyamoya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc Nervous system diseases in the past two years, characterized by transient or fixed neurological deficits (such as partial or secondary generalized seizures of epilepsy, complex or classic migraine, tumor or other intracranial space-occupying lesions, subdural hematoma, brain contusion or other post-traumatic lesions, intracranial infection, demyelinating diseases, intracranial hemorrhage, etc.), which cannot be distinguished from cerebral infarction History of stenting of an intracranial or extracranial artery Presence of any unequivocal cardiac source of embolism Chronic atrial fibrillation; paroxysmal atrial fibrillation or paroxysmal atrial fibrillation in the past 6 months, or a history of paroxysmal atrial fibrillation, requiring long-term anticoagulation Myocardial infarction in the past 30 days Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation Cannot tolerate dual antiplatelet therapy due to known diseases (such as gastrointestinal bleeding) Contraindications to heparin, aspirin, clopidogrel, ticagrelor, anesthesia, or contrast agents Hemoglobin<100g/L, platelet count <100×109/L, international normalized ratio (INR)>1.5, or heparin-related thrombocytopenia or uncorrectable factors leading to bleeding Not suitable for vessel angiography or endovascular interventional therapy (such as morbid obesity; serious vascular tortuosity that hinders the safe introduction of the guiding catheter) Severe hepatic and renal dysfunction Major surgery within the past 30 days or planned within 90 days Renal artery, iliac artery, and coronary artery requiring simultaneous intervention Life expectancy <1 year Pregnant or lactating women Cognitive assessment and follow-up could not be completed due to factors such as severe aphasia, neuropsychological illness or mental illness or dysarthria and inability to communicate History of drug or alcohol abuse, head trauma or central nervous system infection; current use of drugs that affect cognition Combined with diseases that are not suitable for hyperbaric oxygen therapy (such as untreated pneumothorax, uncontrolled epilepsy, claustrophobia, angle-closure glaucoma, cavitary pulmonary tuberculosis, etc.) Enrollment in another study that would conflict with the current study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hyperbaric oxygen therapy plus standard medical treatment

    Standard medical treatment

    Arm Description

    Patients will receive hyperbaric oxygen therapy plus standard medical treatment after stenting

    Patients will receive standard medical treatment after stenting

    Outcomes

    Primary Outcome Measures

    Montreal Cognitive Assessment (MoCA)
    Chinese version of Montreal Cognitive Assessment (MoCA) will be use to assess the cognitive level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 30. Higher scores mean a better outcome.

    Secondary Outcome Measures

    Mini-Mental State Examination (MMSE)
    Chinese version of MMSE will be use to assess the cognitive level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 30. Higher scores mean a better outcome.
    Auditory Verbal Learning Test (AVLT)
    Chinese version of AVLT will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 12. Higher scores mean a better outcome.
    Symbol Digital Modalities Test (SDMT)
    Chinese version of SDMT will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 90. Higher scores mean a better outcome.
    Digit Span Test (DST)
    Chinese version of DST will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 22. Higher scores mean a better outcome.
    Stroop Color-Word Test (Stroop)
    Chinese version of Stroop will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 50. Higher scores mean a better outcome.
    Trail Making Test (TMT)
    Chinese version of TMT will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. Recording time consumption. Shorter time consumptions mean a better outcome.
    Boston Naming Test (BNT)
    Chinese version of BNT will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 30. Higher scores mean a better outcome.
    Verbal Fluence Test (VFT)
    Chinese version of VFT will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. Record the number of correct phrases. Higher scores mean a better outcome.
    Hamilton Anxiety Scale (HAMA)
    Chinese version of HAMA will be use to assess the anxiety level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 64. Higher scores mean a better outcome.
    Hamilton Depression Scale (HAMD)
    Chinese version of HAMD will be use to assess the depression level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 96. Higher scores mean a better outcome.
    Pittsburgh Sleep Quality Index (PSQI)
    Chinese version of PSQI will be use to assess the sleep quality of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 27. Higher scores mean a better outcome.

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    August 6, 2023
    Sponsor
    Beijing Tiantan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05980195
    Brief Title
    Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial
    Official Title
    Cognitive Improvement After cARotid stEnting in HyperBaric Oxygen Therapy Trial (CARE-HBOT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 31, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Tiantan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of CARE-HBOT study is to evaluate whether patients with symptomatic severe carotid artery stenosis with cognitive impairment who underwent hyperbaric oxygen therapy plus standard medical treatment after stent implantation could improve their cognitive function compared with those who underwent standard postoperative medical treatment.
    Detailed Description
    This study is a prospective, multi-center, 1:1 randomized trial. In patients with symptomatic severe carotid artery stenosis with cognitive impairment underwent stent implantation, whether hyperbaric oxygen therapy plus standard medical treatment after stenting could improve their cognitive function compared with those who underwent standard postoperative medical treatment will be studied. Primary endpoint: Cognitive level at 6 months of follow up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carotid Stenosis, Cognitive Impairment, Hyperbaric Oxygen Therapy, Stent Implantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hyperbaric oxygen therapy plus standard medical treatment
    Arm Type
    Experimental
    Arm Description
    Patients will receive hyperbaric oxygen therapy plus standard medical treatment after stenting
    Arm Title
    Standard medical treatment
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive standard medical treatment after stenting
    Intervention Type
    Procedure
    Intervention Name(s)
    Hyperbaric oxygen therapy
    Intervention Description
    Hyperbaric oxygen therapy for 30 times within 50 days
    Intervention Type
    Drug
    Intervention Name(s)
    Standard medical treatment
    Intervention Description
    Standard medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 3 months after stenting). Other Name: Dual antiplatelet therapy for 3 months
    Intervention Type
    Behavioral
    Intervention Name(s)
    Risk factor management
    Intervention Description
    Management of risk factors including hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise
    Primary Outcome Measure Information:
    Title
    Montreal Cognitive Assessment (MoCA)
    Description
    Chinese version of Montreal Cognitive Assessment (MoCA) will be use to assess the cognitive level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 30. Higher scores mean a better outcome.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Mini-Mental State Examination (MMSE)
    Description
    Chinese version of MMSE will be use to assess the cognitive level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 30. Higher scores mean a better outcome.
    Time Frame
    6 months
    Title
    Auditory Verbal Learning Test (AVLT)
    Description
    Chinese version of AVLT will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 12. Higher scores mean a better outcome.
    Time Frame
    6 months
    Title
    Symbol Digital Modalities Test (SDMT)
    Description
    Chinese version of SDMT will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 90. Higher scores mean a better outcome.
    Time Frame
    6 months
    Title
    Digit Span Test (DST)
    Description
    Chinese version of DST will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 22. Higher scores mean a better outcome.
    Time Frame
    6 months
    Title
    Stroop Color-Word Test (Stroop)
    Description
    Chinese version of Stroop will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 50. Higher scores mean a better outcome.
    Time Frame
    6 months
    Title
    Trail Making Test (TMT)
    Description
    Chinese version of TMT will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. Recording time consumption. Shorter time consumptions mean a better outcome.
    Time Frame
    6 months
    Title
    Boston Naming Test (BNT)
    Description
    Chinese version of BNT will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 30. Higher scores mean a better outcome.
    Time Frame
    6 months
    Title
    Verbal Fluence Test (VFT)
    Description
    Chinese version of VFT will be use to assess the cognitive function domain level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. Record the number of correct phrases. Higher scores mean a better outcome.
    Time Frame
    6 months
    Title
    Hamilton Anxiety Scale (HAMA)
    Description
    Chinese version of HAMA will be use to assess the anxiety level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 64. Higher scores mean a better outcome.
    Time Frame
    6 months
    Title
    Hamilton Depression Scale (HAMD)
    Description
    Chinese version of HAMD will be use to assess the depression level of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 96. Higher scores mean a better outcome.
    Time Frame
    6 months
    Title
    Pittsburgh Sleep Quality Index (PSQI)
    Description
    Chinese version of PSQI will be use to assess the sleep quality of the hyperbaric oxygen therapy group (HBOT group) and the control group at 6 months after procedure. The minimum value is 0 and the maximum value is 27. Higher scores mean a better outcome.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age from 18 to 75 years Ischemic stroke or transient ischemic attack (TIA) occurred within 30 days before endovascular stent treatment National Institute of Health stroke scale (NIHSS) ≤3 Culprit vessel was the common carotid artery or extracranial internal carotid artery, involving or not involving the external carotid artery The degree of culprit arterial stenosis is 70-99 % ; based on Digital subtraction angiography (DSA) (According to North American Symptomatic Carotid Endarterectomy Trial (NASCET) method) The diameter of the target vessel between 4.0 mm - 9.0 mm Mini-mental State Examination (MMSE) score : education level-middle school ≤ 24; education level-high school ≤ 20 ; education level-college ≤ 17 Baseline modified Rankin Scale (mRS) score ≤ 3 Patient understands the purpose and requirements of the study, and has provided informed consent Exclusion Criteria: Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion Serious perioperative complications affecting subsequent hyperbaric oxygen therapy (such as cerebral hemorrhage, disabling stroke, etc.) Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 12 months Hemorrhagic transformation after ischemic stroke within 60 days before enrollment Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, Moyamoya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc Nervous system diseases in the past two years, characterized by transient or fixed neurological deficits (such as partial or secondary generalized seizures of epilepsy, complex or classic migraine, tumor or other intracranial space-occupying lesions, subdural hematoma, brain contusion or other post-traumatic lesions, intracranial infection, demyelinating diseases, intracranial hemorrhage, etc.), which cannot be distinguished from cerebral infarction History of stenting of an intracranial or extracranial artery Presence of any unequivocal cardiac source of embolism Chronic atrial fibrillation; paroxysmal atrial fibrillation or paroxysmal atrial fibrillation in the past 6 months, or a history of paroxysmal atrial fibrillation, requiring long-term anticoagulation Myocardial infarction in the past 30 days Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation Cannot tolerate dual antiplatelet therapy due to known diseases (such as gastrointestinal bleeding) Contraindications to heparin, aspirin, clopidogrel, ticagrelor, anesthesia, or contrast agents Hemoglobin<100g/L, platelet count <100×109/L, international normalized ratio (INR)>1.5, or heparin-related thrombocytopenia or uncorrectable factors leading to bleeding Not suitable for vessel angiography or endovascular interventional therapy (such as morbid obesity; serious vascular tortuosity that hinders the safe introduction of the guiding catheter) Severe hepatic and renal dysfunction Major surgery within the past 30 days or planned within 90 days Renal artery, iliac artery, and coronary artery requiring simultaneous intervention Life expectancy <1 year Pregnant or lactating women Cognitive assessment and follow-up could not be completed due to factors such as severe aphasia, neuropsychological illness or mental illness or dysarthria and inability to communicate History of drug or alcohol abuse, head trauma or central nervous system infection; current use of drugs that affect cognition Combined with diseases that are not suitable for hyperbaric oxygen therapy (such as untreated pneumothorax, uncontrolled epilepsy, claustrophobia, angle-closure glaucoma, cavitary pulmonary tuberculosis, etc.) Enrollment in another study that would conflict with the current study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Weilun Fu
    Phone
    +86-010-59978857
    Email
    doctorfwl@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ning Ma
    Organizational Affiliation
    Beijing Tiantan Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    18087057
    Citation
    Wolff T, Guirguis-Blake J, Miller T, Gillespie M, Harris R. Screening for carotid artery stenosis: an update of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2007 Dec 18;147(12):860-70. doi: 10.7326/0003-4819-147-12-200712180-00006.
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    Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial

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