Health TrialsbyHealthPanel

Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial

ConditionsCarotid StenosisCognitive ImpairmentHyperbaric Oxygen TherapyStent Implantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperbaric oxygen therapy

    Procedure/Surgery

    Hyperbaric oxygen therapy for 30 times within 50 days

  • Standard medical treatment

    Drug

    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

  • Risk factor management

    Behavioral

    Management of risk factors including hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Hyperbaric oxygen therapy plus standard medical treatmentExperimental treatment 3 interventions
Group B: Standard medical treatmentActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: