Cognitive Improvement After cARotid stEnting in HyperBaric Oxygen Therapy Trial (CARE-HBOT)
Overview
- Phase
- Not Applicable
- Intervention
- Hyperbaric oxygen therapy
- Conditions
- Carotid Stenosis
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 90
- Primary Endpoint
- Montreal Cognitive Assessment (MoCA)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age from 18 to 75 years
- •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
Arms & Interventions
Hyperbaric oxygen therapy plus standard medical treatment
Patients will receive hyperbaric oxygen therapy plus standard medical treatment after stenting
Intervention: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy plus standard medical treatment
Patients will receive hyperbaric oxygen therapy plus standard medical treatment after stenting
Intervention: Standard medical treatment
Hyperbaric oxygen therapy plus standard medical treatment
Patients will receive hyperbaric oxygen therapy plus standard medical treatment after stenting
Intervention: Risk factor management
Standard medical treatment
Patients will receive standard medical treatment after stenting
Intervention: Standard medical treatment
Standard medical treatment
Patients will receive standard medical treatment after stenting
Intervention: Risk factor management
Outcomes
Primary Outcomes
Montreal Cognitive Assessment (MoCA)
Time Frame: 6 months
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 Outcomes
- Mini-Mental State Examination (MMSE)(6 months)
- Auditory Verbal Learning Test (AVLT)(6 months)
- Symbol Digital Modalities Test (SDMT)(6 months)
- Digit Span Test (DST)(6 months)
- Stroop Color-Word Test (Stroop)(6 months)
- Trail Making Test (TMT)(6 months)
- Boston Naming Test (BNT)(6 months)
- Verbal Fluence Test (VFT)(6 months)
- Hamilton Anxiety Scale (HAMA)(6 months)
- Hamilton Depression Scale (HAMD)(6 months)
- Pittsburgh Sleep Quality Index (PSQI)(6 months)