Research on Ultrasound Diagnostic Criteria for Intracranial and Extracranial Arterial Serial Stenosis

Capital Medical University

Status: Not yet enrolling

Conditions: Ischemic Stroke; Carotid Stenosis

Treatments: Procedure: stenting

Study type: Observational

Funder types: Other

Identifiers

NCT06947720

xwzc202500203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

700 participants in 10 patient groups

Mild stenosis group without collateral circulation

Description:

There is no anterior communicating artery, posterior communicating artery, or internal external carotid artery in the skull, and the degree of stenosis in the V4 segment of the middle cerebral artery or vertebral artery is less than 50%

Treatment:

Procedure: stenting

Group without collateral circulation and stenosis

Description:

There is no anterior communicating artery, posterior communicating artery, or internal carotid external artery in the skull, and there is no stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery.

Treatment:

Procedure: stenting

Moderate stenosis group without collateral circulation

Description:

There is no anterior communicating artery, posterior communicating artery, or internal carotid external artery in the skull, and the degree of stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery is 50-69%.

Treatment:

Procedure: stenting

Severe stenosis group without collateral circulation

Description:

There is no anterior communicating artery, posterior communicating artery, or internal carotid external artery in the skull, and the degree of stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery is 70-99%.

Treatment:

Procedure: stenting

Group with collateral circulation and no stenosis

Description:

There are anterior or posterior communicating arteries or internal external carotid arteries in the skull, and there is no stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery.

Treatment:

Procedure: stenting

Mild stenosis of collateral circulation group

Description:

There are anterior or posterior communicating arteries or internal external carotid arteries in the skull, and the degree of stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery is less than 50%.

Treatment:

Procedure: stenting

Moderate stenosis of collateral circulation group

Description:

There are anterior or posterior communicating arteries or internal external carotid arteries in the skull, and the degree of stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery is 50-69%.

Treatment:

Procedure: stenting

Group with severe stenosis of collateral circulation

Description:

There are anterior or posterior communicating arteries or internal external carotid arteries in the skull, and the degree of stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery is 70-99%.

Treatment:

Procedure: stenting

End event group

Description:

During the 1-year follow-up after surgery, the patient experienced new stroke events such as ischemic stroke, transient ischemic attack, and hemorrhagic stroke.

Treatment:

Procedure: stenting

Group without endpoint events

Description:

At the 1-year follow-up after surgery, the patient did not experience any new stroke events such as ischemic stroke, transient ischemic attack, or hemorrhagic stroke.

Treatment:

Procedure: stenting