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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Hyperbaric oxygen therapy for 30 times within 50 days
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
Management of risk factors including hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months