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Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial | Clinical Trials | Clareo Health

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Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial

Cognitive Improvement After cARotid stEnting in HyperBaric Oxygen Therapy Trial (CARE-HBOT)

NCT05980195•Beijing Tiantan Hospital

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age from 18 to 75 years
•2. National Institute of Health stroke scale (NIHSS) ≤3
•3. Culprit vessel was the common carotid artery or extracranial internal carotid artery, involving or not involving the external carotid artery
•4. 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)
•5. The diameter of the target vessel between 4.0 mm - 9.0 mm
•6. Mini-mental State Examination (MMSE) score : education level-middle school ≤ 24; education level-high school ≤ 20 ; education level-college ≤ 17
•7. Baseline modified Rankin Scale (mRS) score ≤ 3
•8. Patient understands the purpose and requirements of the study, and has provided informed consent

Exclusion Criteria

•1. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion
•2. Serious perioperative complications affecting subsequent hyperbaric oxygen therapy (such as cerebral hemorrhage, disabling stroke, etc.)
•3. Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 12 months
•4. Hemorrhagic transformation after ischemic stroke within 60 days before enrollment
•5. 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
•6. 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
•7. History of stenting of an intracranial or extracranial artery
•8. Presence of any unequivocal cardiac source of embolism
•9. 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
•10. Myocardial infarction in the past 30 days
+14 more criteria

Key Dates

Start Date

July 16, 2024

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

July 18, 2024

Enrollment

ESTIMATED participants

Conditions

Carotid StenosisCognitive ImpairmentHyperbaric Oxygen TherapyStent Implantation

Interventions

Hyperbaric oxygen therapy

PROCEDURE

Standard medical treatment

DRUG

Risk factor management

BEHAVIORAL

Contacts

Weilun Fu

CONTACT

+86-010-59978857 doctorfwl@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial

Inclusion Criteria

Exclusion Criteria

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