Carotid StenosisNCT05980195
Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial
A study testing Hyperbaric oxygen therapy, Standard medical treatment and Risk factor management in people with Carotid Stenosis and Cognitive Impairment, run by Beijing Tiantan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carotid Stenosis, Cognitive Impairment, Hyperbaric Oxygen Therapy
- What is being tested?
- Hyperbaric oxygen therapy, Standard medical treatment and Risk factor management
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 16 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cognitive Improvement After cARotid stEnting in HyperBaric Oxygen Therapy Trial (CARE-HBOT)
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.
Read the 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.
- Being tested
- Hyperbaric oxygen therapy, Standard medical treatment, Risk factor management
- Medical subject headings
- Carotid Stenosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyProcedure or surgery
Hyperbaric oxygen therapy for 30 times within 50 days
Standard medical treatmentDrug
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 managementBehavioural
Management of risk factors including hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy plus standard medical treatment | Experimental | Patients will receive hyperbaric oxygen therapy plus standard medical treatment after stenting Receives: Procedure: Hyperbaric oxygen therapy; Drug: Standard medical treatment; Behavioral: Risk factor management |
| Standard medical treatment | Active comparator | Patients will receive standard medical treatment after stenting Receives: Drug: Standard medical treatment; Behavioral: Risk factor management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start16 Jul 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Ma, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980195
- Sponsor's protocol ID
- CH2023-06-13
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2023
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18087057Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
PubMed 28122885Sardar P, Chatterjee S, Aronow HD, Kundu A, Ramchand P, Mukherjee D, Nairooz R, Gray WA, White CJ, Jaff MR, Rosenfield K, Giri J. Carotid Artery Stenting Versus Endarterectomy for Stroke Prevention: A Meta-Analysis of Clinical Trials. J Am Coll Cardiol. 2017 May 9;69(18):2266-2275. doi: 10.1016/j.jacc.2017.02.053.
PubMed 28473130Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
PubMed 34024117Bonati LH, Kakkos S, Berkefeld J, de Borst GJ, Bulbulia R, Halliday A, van Herzeele I, Koncar I, McCabe DJ, Lal A, Ricco JB, Ringleb P, Taylor-Rowan M, Eckstein HH. European Stroke Organisation guideline on endarterectomy and stenting for carotid artery stenosis. Eur Stroke J. 2021 Jun;6(2):I-XLVII. doi: 10.1177/23969873211012121. Epub 2021 May 11.
PubMed 34414302Sztriha LK, Nemeth D, Sefcsik T, Vecsei L. Carotid stenosis and the cognitive function. J Neurol Sci. 2009 Aug 15;283(1-2):36-40. doi: 10.1016/j.jns.2009.02.307. Epub 2009 Mar 9.
PubMed 19269651Altinbas A, van Zandvoort MJ, van den Berg E, Jongen LM, Algra A, Moll FL, Nederkoorn PJ, Mali WP, Bonati LH, Brown MM, Kappelle LJ, van der Worp HB. Cognition after carotid endarterectomy or stenting: a randomized comparison. Neurology. 2011 Sep 13;77(11):1084-90. doi: 10.1212/WNL.0b013e31822e55b9. Epub 2011 Aug 31.
PubMed 21880992Huang P, He XY, Xu M. Effects of Carotid Artery Stent and Carotid Endarterectomy on Cognitive Function in Patients with Carotid Stenosis. Biomed Res Int. 2020 Dec 16;2020:6634537. doi: 10.1155/2020/6634537. eCollection 2020.
PubMed 33381568Gottfried I, Schottlender N, Ashery U. Hyperbaric Oxygen Treatment-From Mechanisms to Cognitive Improvement. Biomolecules. 2021 Oct 15;11(10):1520. doi: 10.3390/biom11101520.
PubMed 34680155Hadanny A, Rittblat M, Bitterman M, May-Raz I, Suzin G, Boussi-Gross R, Zemel Y, Bechor Y, Catalogna M, Efrati S. Hyperbaric oxygen therapy improves neurocognitive functions of post-stroke patients - a retrospective analysis. Restor Neurol Neurosci. 2020;38(1):93-107. doi: 10.3233/RNN-190959.
PubMed 31985478
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Improvement After cARotid stEnting in HyperBaric Oxygen Therapy Trial (CARE-HBOT)
- ClinicalTrials.gov ID
- NCT05980195
- Acronym / sponsor ID
- CH2023-06-13
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 16 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy plus standard medical treatment | Experimental | Procedure: Hyperbaric oxygen therapy, Drug: Standard medical treatment, Behavioral: Risk factor managementPatients will receive hyperbaric oxygen therapy plus standard medical treatment after stenting |
| Standard medical treatment | Active comparator | Drug: Standard medical treatment, Behavioral: Risk factor managementPatients will receive standard medical treatment after stenting |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyHyperbaric oxygen therapy for 30 times within 50 days | Procedure or surgery | Hyperbaric oxygen therapy plus standard medical treatment |
| Standard medical treatmentStandard 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 | Drug | Hyperbaric oxygen therapy plus standard medical treatment, Standard medical treatment |
| Risk factor managementManagement of risk factors including hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise | Behavioural | Hyperbaric oxygen therapy plus standard medical treatment, Standard medical treatment |
Primary outcome
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.
11 secondary outcomes
Mini-Mental State Examination (MMSE)
Time frame: 6 months
Auditory Verbal Learning Test (AVLT)
Time frame: 6 months
Symbol Digital Modalities Test (SDMT)
Time frame: 6 months
Digit Span Test (DST)
Time frame: 6 months
Stroop Color-Word Test (Stroop)
Time frame: 6 months
Trail Making Test (TMT)
Time frame: 6 months
Boston Naming Test (BNT)
Time frame: 6 months
Verbal Fluence Test (VFT)
Time frame: 6 months
Hamilton Anxiety Scale (HAMA)
Time frame: 6 months
Hamilton Depression Scale (HAMD)
Time frame: 6 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Background: PubMed 18087057Wolff 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.
- Background: PubMed 28122885Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
- Background: PubMed 28473130Sardar P, Chatterjee S, Aronow HD, Kundu A, Ramchand P, Mukherjee D, Nairooz R, Gray WA, White CJ, Jaff MR, Rosenfield K, Giri J. Carotid Artery Stenting Versus Endarterectomy for Stroke Prevention: A Meta-Analysis of Clinical Trials. J Am Coll Cardiol. 2017 May 9;69(18):2266-2275. doi: 10.1016/j.jacc.2017.02.053.
- Background: PubMed 34024117Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
- Background: PubMed 34414302Bonati LH, Kakkos S, Berkefeld J, de Borst GJ, Bulbulia R, Halliday A, van Herzeele I, Koncar I, McCabe DJ, Lal A, Ricco JB, Ringleb P, Taylor-Rowan M, Eckstein HH. European Stroke Organisation guideline on endarterectomy and stenting for carotid artery stenosis. Eur Stroke J. 2021 Jun;6(2):I-XLVII. doi: 10.1177/23969873211012121. Epub 2021 May 11.
- Background: PubMed 19269651Sztriha LK, Nemeth D, Sefcsik T, Vecsei L. Carotid stenosis and the cognitive function. J Neurol Sci. 2009 Aug 15;283(1-2):36-40. doi: 10.1016/j.jns.2009.02.307. Epub 2009 Mar 9.
- Background: PubMed 21880992Altinbas A, van Zandvoort MJ, van den Berg E, Jongen LM, Algra A, Moll FL, Nederkoorn PJ, Mali WP, Bonati LH, Brown MM, Kappelle LJ, van der Worp HB. Cognition after carotid endarterectomy or stenting: a randomized comparison. Neurology. 2011 Sep 13;77(11):1084-90. doi: 10.1212/WNL.0b013e31822e55b9. Epub 2011 Aug 31.
- Background: PubMed 33381568Huang P, He XY, Xu M. Effects of Carotid Artery Stent and Carotid Endarterectomy on Cognitive Function in Patients with Carotid Stenosis. Biomed Res Int. 2020 Dec 16;2020:6634537. doi: 10.1155/2020/6634537. eCollection 2020.
- Background: PubMed 34680155Gottfried I, Schottlender N, Ashery U. Hyperbaric Oxygen Treatment-From Mechanisms to Cognitive Improvement. Biomolecules. 2021 Oct 15;11(10):1520. doi: 10.3390/biom11101520.
- Background: PubMed 31985478Hadanny A, Rittblat M, Bitterman M, May-Raz I, Suzin G, Boussi-Gross R, Zemel Y, Bechor Y, Catalogna M, Efrati S. Hyperbaric oxygen therapy improves neurocognitive functions of post-stroke patients - a retrospective analysis. Restor Neurol Neurosci. 2020;38(1):93-107. doi: 10.3233/RNN-190959.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Ma principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen therapy, Standard medical treatment and Risk factor management in people with Carotid Stenosis and Cognitive Impairment, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weilun Fu (+86-010-59978857, doctorfwl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05980195, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.