Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05980195
• Other study ID #: CH2023-06-13
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Beijing Tiantan Hospital
• Contact: Weilun Fu
• Phone: +86-010-59978857
• Email: doctorfwl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 postoperative medical treatment.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age from 18 to 75 years

2. Ischemic stroke or transient ischemic attack (TIA) occurred within 180 days before endovascular stent treatment

3. National Institute of Health stroke scale (NIHSS) =3

4. Culprit vessel was the common carotid artery or extracranial internal carotid artery, involving or not involving the external carotid artery

5. 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)

6. The diameter of the target vessel between 4.0 mm - 9.0 mm

7. Mini-mental State Examination (MMSE) score : education level-middle school = 24; education level-high school = 20 ; education level-college = 17

8. Baseline modified Rankin Scale (mRS) score = 3

9. 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

11. Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation

12. Cannot tolerate dual antiplatelet therapy due to known diseases (such as gastrointestinal bleeding)

13. Contraindications to heparin, aspirin, clopidogrel, ticagrelor, anesthesia, or contrast agents

14. Hemoglobin<100g/L, platelet count <100×109/L, international normalized ratio (INR)>1.5, or heparin-related thrombocytopenia or uncorrectable factors leading to bleeding

15. 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)

16. Severe hepatic and renal dysfunction

17. Major surgery within the past 30 days or planned within 90 days

18. Renal artery, iliac artery, and coronary artery requiring simultaneous intervention

19. Life expectancy <1 year

20. Pregnant or lactating women

21. 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

22. History of drug or alcohol abuse, head trauma or central nervous system infection; current use of drugs that affect cognition

23. 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.)

24. Enrollment in another study that would conflict with the current study

Related Conditions & MeSH terms

• Carotid Stenosis
• Cognitive Impairment
• Hyperbaric Oxygen Therapy

Intervention

Procedure:
• Hyperbaric oxygen therapy
Hyperbaric oxygen therapy for 30 times within 50 days

Drug:
• Standard medical treatment
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

Behavioral:
• Risk factor management
Management of risk factors including hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

References & Publications (10)

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. — View Citation

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. Circulation. 2017 Sep 5;136(10 ):e196. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Stroke. 2021 Jul;52(7):e483-e484. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months