Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial

NCT05980195 | Not Yet Recruiting

• 1 other identifier: CH2023-06-13
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carotid Stenosis; Cognitive Impairment; Hyperbaric Oxygen Therapy; Stent Implantation

Outcome Measures

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.

  6 months

Secondary Outcomes (11)

• 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

Study Arms (2)

Hyperbaric oxygen therapy plus standard medical treatment

EXPERIMENTAL

Patients will receive hyperbaric oxygen therapy plus standard medical treatment after stenting

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

Drug: Standard medical treatment; Behavioral: Risk factor management

Interventions

Hyperbaric oxygen therapy PROCEDURE

Hyperbaric oxygen therapy for 30 times within 50 days

Hyperbaric oxygen therapy plus standard medical treatment

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

Hyperbaric oxygen therapy plus standard medical treatment; Standard medical treatment

Risk factor management BEHAVIORAL

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

Hyperbaric oxygen therapy plus standard medical treatment; Standard medical treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Related Publications (10)

• 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.

  PMID: 18087057 BACKGROUND

• Benjamin 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. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

  PMID: 28122885 BACKGROUND

• Sardar 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.

  PMID: 28473130 BACKGROUND

• Kleindorfer 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.

  PMID: 34024117 BACKGROUND

• Bonati 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.

  PMID: 34414302 BACKGROUND

• Sztriha 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.

  PMID: 19269651 BACKGROUND

• Altinbas 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.

  PMID: 21880992 BACKGROUND

• Huang 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.

  PMID: 33381568 BACKGROUND

• Gottfried I, Schottlender N, Ashery U. Hyperbaric Oxygen Treatment-From Mechanisms to Cognitive Improvement. Biomolecules. 2021 Oct 15;11(10):1520. doi: 10.3390/biom11101520.

  PMID: 34680155 BACKGROUND

• Hadanny 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.

  PMID: 31985478 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis; Cognitive Dysfunction

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Ning Ma

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weilun Fu

CONTACT

+86-010-59978857; doctorfwl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 7, 2023
• Study Start: July 16, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share