Prediction of Hyperperfusion After Carotid Stenting by Multi-parameter Characteristics Based on Cerebral Autoregulation

NCT06058676 | Enrolling By Invitation DMC

• 1 other identifier: 2023-9-15
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral hyperperfusion syndrome (CHS) is one of the severe complication after carotid artery stenting with a high mortality rate. CHS was defined as cerebral hyperperfusion (CH) with clinical symptoms such as unilateral headache, convulsions, hemiparesis/hemiplegia, visual disturbances, ataxia, aphasia, while CH could be a disastrous outcome causing complication after carotid revascularization if not managed properly and timely. This is a single-center prospective cohort study to investigate the risks of CH after carotid artery stenting. All patients with severe carotid artery stenosis underwent carotid arterial ultrasonography and dynamic cerebral autoregulation (dCA) test by transcranial Doppler sonography (TCD) before operation. The postoperative carotid ultrasound and transcranial Doppler sonography (TCD) results are also needed. The investigators will collect this test data at 48h, 1 month and 3months after carotid artery stenting（CAS）. According to the examination results, they were divided into two groups: CH group and non-CH group. The investigators will collect data before CAS, on all participants' age, sex, heart rate, BP and end-tidal carbon dioxide (ET-CO2) and the following information from the patients : (i)demographic data, such as hypertension, coronary heart disease, diabetes, hyperlipidemia, smoking and body mass index; (ii) relevant clinical symptoms; (iii) preoperative colour Doppler ultrasonography（CDU）and transcranial Doppler sonography(TCD) results; (iv) The cerebral blood flow velocity (CBFV) of the middle cerebral artery（MCA） induced will be measured by non-invasively and continuously dCA test. This study could be aimed to analyze the factors influencing cerebral hyperperfusion after CAS. The purpose of this study will be to perform more precise risk stratification for high-risk CH patients and improve the quality of life of them. Statistical Analysis The Statistical Package for the Social Sciences（SPSS）software Version 26.0 (IBM, New York, USA) will be used for statistical analyses. The indicators with P \< 0.2 in the univariate analysis will be entered into a logistic regression analysis to investigate the independent risk factors for CH after CAS. All tests will be performed two sided, and a P \< 0.05 will be considered statistically significant.

Conditions

Cerebral Artery Stenosis; Carotid Artery Stent; Dynamic Cerebral Autoregulation

Keywords

Ultrasonography; Carotid artery stent; Dynamic cerebral autoregulation; Cerebral hyperperfusion; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• Cerebral hyperperfusion

  Postoperative CH will be defined in patients whose MCA mean velocity increased by more than 100% after carotid artery stent.

  within 7 days post-operation

Secondary Outcomes (2)

• Cerebral hyperperfusion syndrome

  with 1 month post-operation

• Major stroke

  within 7 days post-operation

Study Arms (2)

Patients with reduced cerebrovascular reserve

Interventions: Procedure: carotid artery stenting

Procedure: carotid artery stenting

Patients with sufficient cerebrovascular reserve

Interventions: Procedure: carotid artery stenting

Procedure: carotid artery stenting

Interventions

carotid artery stenting PROCEDURE

The procedures will be performed for patients with general or local anesthesia. Implantation of stents at the site of carotid artery stenosis for the treatment of carotid severe stenosis. A suitable balloon will be selected based on the internal carotid arterial（ICA）diameter, as shown on the digital subtraction angiography（DSA）image. The use of a balloon for predilatation or postdilatation depends on the degree of stenosis. The type of stent will be selected according to several factors, such as the length and configuration of the lesion, vascular morphology, vessel diameter, plaque characteristics, stent characteristics, and surgeon experience.

Patients with reduced cerebrovascular reserve; Patients with sufficient cerebrovascular reserve

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients 18 years of age and older. Symptomatic patients with internal carotid artery stenosis≥50% on angiography, or asymptomatic patients with internal carotid artery stenosis≥70% on angiography.

You may qualify if:

• (1) Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 18 years and ≤ 80.
• (2) Symptomatic patients with internal carotid artery stenosis≥50% on angiography, or asymptomatic patients with internal carotid artery stenosis≥70% on angiography treatable with carotid artery stenting.
• (3) Patient is willing and capable of complying with all study protocol requirements, including the specified follow-up visits and can be contacted by telephone.

You may not qualify if:

• (1) Patients with severe carotid artery stenosis caused by non-atherosclerosis diseases, such as dissection or arteritis.
• (2) Inability to cooperate with all this examination.
• (3) Patients without complete clinical or imaging information.
• (4) Patients not evaluated by CDU before CAS or within 1 week after CAS.
• (5) Lack of follow up with CDU after CAS.
• (6) Patients with poor temporal sound window or closure of the temporal window.
• (7) Hyperthyroidism, hemicrania, severe arrhythmia and other diseases affecting dCA.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (3)

• Bonow RH, Young CC, Bass DI, Moore A, Levitt MR. Transcranial Doppler ultrasonography in neurological surgery and neurocritical care. Neurosurg Focus. 2019 Dec 1;47(6):E2. doi: 10.3171/2019.9.FOCUS19611.

  PMID: 31786564 BACKGROUND

• Liu Y, Tarumi T, Liu B, Li J, Wu X, Zhang N, Hua Y. Dynamic Cerebral Autoregulation in Preclinical Atherosclerotic Cardiovascular Disease. J Stroke Cerebrovasc Dis. 2020 Jun;29(6):104810. doi: 10.1016/j.jstrokecerebrovasdis.2020.104810. Epub 2020 Apr 11.

  PMID: 32291129 BACKGROUND

• Panerai RB, Brassard P, Burma JS, Castro P, Claassen JA, van Lieshout JJ, Liu J, Lucas SJ, Minhas JS, Mitsis GD, Nogueira RC, Ogoh S, Payne SJ, Rickards CA, Robertson AD, Rodrigues GD, Smirl JD, Simpson DM; Cerebrovascular Research Network (CARNet). Transfer function analysis of dynamic cerebral autoregulation: A CARNet white paper 2022 update. J Cereb Blood Flow Metab. 2023 Jan;43(1):3-25. doi: 10.1177/0271678X221119760. Epub 2022 Aug 12.

  PMID: 35962478 BACKGROUND

Study Officials

• yingqi Xing, MD

  Department of Vascular Ultrasonography, Xuanwu Hospital. Beijing Institute of Brain Disorders.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)