Carotid Asymptomatic Stenosis

NCT04825080 | Unknown

• 1 other identifier: STECA
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

There is debate on the natural history of asymptomatic severe carotid artery stenosis. Previous studies conducted more than 20 years ago revealed the benefit of carotid endarterectomy compared with medical therapy only on the stroke prevention. However, today it seems that the current medical regimen can reduce the cerebral ischemic event rate in patients with asymptomatic severe carotid artery stenosis to less than 1% per year, making it questionable to choose the surgical treatment.

Conditions

Asymptomatic Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (2)

• Cerebral ischemic events

  Stroke and transient cerebral ischemic events or amaurosis fugax, evaluated by clinical neurologist by clinical examination (National Institutes of Health Stroke Scale, NIHSS or modified Rankin scale, mRS)

  5 years

• Ipsilateral cerebral ischemic events

  Ipsilateral stroke and transient cerebral ischemic events or amaurosis fugax, evaluated by clinical neurologist by clinical examination (National Institutes of Health Stroke Scale, NIHSS or modified Rankin scale, mRS)

  5 years

Secondary Outcomes (3)

• Plaque progression

  5 years

• Patient's adherence to the medical therapy

  5 years

• Survival

  5 years

Interventions

duplex ultrasound and computed tomography angiography DIAGNOSTIC_TEST

Identification of carotid artery stenosis \> 60% NASCET criteria

Eligibility Criteria

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

Study Population

Patients are prospectively identified and enrolled in a single center vascular surgery ambulatory and a duplex ultrasonography (DUS) laboratory. Carotid artery stenosis are identified and the degree of stenosis \>60% is evaluated according to the current guidelines for stenosis identification through blood flow velocities. Patients enrollment goes from January 2019 to March 2020. The investigators prospectively complete the dedicated database including clinical characteristics, cardiovascular risk factors, medical therapy in use, features of the carotid plaque and contralateral carotid status.

You may qualify if:

• \- asymptomatic carotid artery stenosis (according to the ESVS guidelines) \>60% (NASCET criteria) with a physical examination and a DUS at the S. Orsola Malpighi hospital from 2019 to 2025.

You may not qualify if:

• Patients submitted to carotid revascularization will be included until the revascularization.
• Patients who underwent a transient ischemic attach or a stroke within the 6-months before the enrollment are excluded from the study
• Restenosis
• Carotid total occlusion

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Policlinico S. Orsola Malpighi

Bologna, 40138, Italy

Location

MeSH Terms

Interventions

Ultrasonography, Doppler, Duplex; Computed Tomography Angiography

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2025
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)