Clinical trial NCT06947720: Research on Ultrasound Diagnostic Criteria for Intracranial and Extracranial Arterial Serial Stenosis
Official title: Research on Ultrasound Diagnostic Criteria for Intracranial and Extracranial Arterial Serial Stenosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ischemic Stroke
Carotid Stenosis
Keywords: Serial stenosis
hemodynamics
Ultrasound diagnostic criteria
prediction model
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients over 18 years old with severe stenosis of the extracranial segment of the internal carotid artery or severe stenosis of the initial segment of the unilateral vertebral artery, who undergo carotid or vertebral artery stenting

Brief summary: This study utilized different hemodynamic parameters of transcranial color-coded Doppler (TCCD) and transcranial Doppler (TCD) to conduct ultrasonic grading evaluation on middle cerebral artery (MCA) stenosis severity in patients with severe extracranial internal carotid artery stenosis, as well as intracranial V4 segment stenosis severity in patients with severe vertebral artery (VA) origin stenosis. The aim was to establish ultrasonic diagnostic criteria and provide reference basis for clinical treatment decision-making. Clarify the distribution of stroke risk factors, establish and evaluate stroke risk identification and prediction models. Patient cohort: Individuals undergoing carotid artery stenting or vertebral artery stenting, including those with either 1) severe extracranial internal carotid artery stenosis combined with ipsilateral MCA tandem stenosis, or 2) unilateral severe vertebral artery origin stenosis combined with intracranial V4 segment tandem stenosis. Collected data included demographic information, vascular ultrasound findings, and imaging examination results. All patients underwent a 1-year follow-up investigation documenting follow-up vascular ultrasound results, laboratory test results, imaging findings, clinical symptoms (ischemic stroke, transient ischemic attack, hemorrhagic stroke), and occurrence of endpoint events.

Detailed description: This study retrospectively and consecutively enrolled 700 patients diagnosed with either 1) severe extracranial internal carotid artery stenosis combined with ipsilateral middle cerebral artery (MCA) tandem stenosis, or 2) unilateral severe vertebral artery (VA) origin stenosis combined with intracranial V4 segment tandem stenosis, who underwent carotid artery stenting or vertebral artery stenting at our institution. Demographic information, vascular ultrasound findings, and imaging examination results were collected and recorded. All enrolled patients underwent a 1-year follow-up investigation. Follow-up data included vascular ultrasound results, laboratory test results, imaging findings, clinical symptoms (ischemic stroke, transient ischemic attack, hemorrhagic stroke), and documentation of endpoint events. The primary endpoint was the 12-month incidence of new-onset stroke events, defined as ischemic stroke, transient ischemic attack, or hemorrhagic stroke.

The study utilized transcranial color-coded Doppler (TCCD) and transcranial Doppler (TCD) hemodynamic parameters to ultrasonically grade MCA stenosis severity in patients with severe extracranial internal carotid artery stenosis and intracranial V4 segment stenosis severity in patients with severe VA origin stenosis. The goal was to establish ultrasound diagnostic criteria and provide a reference basis for clinical treatment decision-making. Additionally, the distribution of stroke risk factors was analyzed, and a risk identification and prediction model for stroke was developed and evaluated.

Patients were first stratified into two groups based on the presence or absence of collateral circulation. Further subgroup classification was performed according to the degree of MCA stenosis (on digital subtraction angiography \[DSA\]) or V4 segment stenosis: no stenosis, mild stenosis, moderate stenosis, and severe stenosis. Finally, patients were categorized into either the endpoint event group or the non-event group based on the occurrence of endpoint events during follow-up.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed by carotid ultrasound with severe stenosis of the extracranial segment of the internal carotid artery or severe stenosis of the initial segment of the unilateral vertebral artery;
2. Perform stent placement surgery within 2 weeks of ultrasound examination, and perform DSA and CTA examinations;
3. Age ≥ 18 years old;
4. Clinical data is complete.

Exclusion Criteria:

1. Bilateral temporal windows are not transparent to sound;
2. Patients with severe stenosis of the extracranial segment of the internal carotid artery have ipsilateral MCA occlusion/ipsilateral common carotid artery severe stenosis or occlusion;
3. Patients with severe stenosis of the extracranial segment of the internal carotid artery have severe stenosis of the contralateral carotid artery;
4. Patients with severe stenosis or occlusion of the anterior circulation in the initial segment of unilateral vertebral artery;
5. Severe stenosis or occlusion of bilateral subclavian arteries;
6. Vasospasm caused by subarachnoid hemorrhage, etc;
7. Related MCA or vertebral artery thrombolysis or endovascular treatment;
8. Arrhythmias such as atrial fibrillation or heart failure that affect velocity measurement;
9. CT, MRI, DSA examination contraindications or refusal of examination;
10. Severe bleeding disorders or coagulation dysfunction;
11. Merge serious diseases of other organs or tissues.

Primary outcomes:
measure: Ultrasound diagnostic criteria for serial stenosis
timeFrame: From preoperative TCCD assessment to surgical completion
measure: The occurrence of the endpoint event
timeFrame: Within 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Vascular Ultrasound, Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Vascular Ultrasound Diagnosis Department, Xuanwu Hospital
name: Yingqi Xing
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ballotta E, Toniato A, Da Roit A, Baracchini C. Clinical Outcomes of Carotid Endarterectomy in Symptomatic and Asymptomatic Patients with Ipsilateral Intracranial Stenosis. World J Surg. 2015 Nov;39(11):2823-30. doi: 10.1007/s00268-015-3165-7.
citation: Ryu JC, Lee SH, Yoo JS, Kwon B, Song Y, Lee DH, Bae JH, Chang JY, Kang DW, Kwon SU, Kim JS, Kim BJ. Prognosis of Proximal and Distal Vertebrobasilar Artery Stent Placement. AJNR Am J Neuroradiol. 2024 Nov 7;45(11):1685-1691. doi: 10.3174/ajnr.A8389.
citation: Zhang J, Xing Y, Cui L. Duplex Ultrasonography for the Evaluation of Extracranial Vertebral Artery: A Prospective Comparison With Digital Subtraction Angiography. Front Neurol. 2022 Jun 27;13:814972. doi: 10.3389/fneur.2022.814972. eCollection 2022.
citation: Liu S, Huang ZL, Sun YR, Liu L, Qi H, Wei LY. Application value of transcranial contrast-enhanced ultrasonography in evaluating middle cerebral artery stenosis. Eur Rev Med Pharmacol Sci. 2023 Jan;27(1):224-232. doi: 10.26355/eurrev_202301_30875.