Reproducibility Study of Transcranial Doppler

University of Edinburgh

Status: Completed

Conditions: Stroke

Treatments: Diagnostic Test: Transcranial Doppler Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT03050567

AC16131

Details and patient eligibility

About

Hardening of the neck vessels (carotid arteries) caused by fatty deposits called 'plaques' is a common cause of strokes. Over time plaques can burst or may lead to a severe narrowing (stenosis) of the neck artery. When plaques burst, small clots or fatty particles (called microemboli) break off, block brain vessels and lead to a stroke. Researchers have an incomplete understanding of the processes that cause hardening of the arteries, development of small clots and are unable to predict who will have a stroke. At present, the only ultrasound scan that evaluates circulation in the head and detects these small clots is called the Transcranial Doppler ultrasound. The aim of the study is to test this simple ultrasound technique to see if it can detect signals that may correspond to these small clots or fatty particles. The other objective is to see how repeatable the ultrasound technique is. This may help to identify patients with hardened neck arteries who are at higher risk of a recurrent stroke. This could also potentially improve patients selection to a targeted surgical or future novel pharmacological therapy.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers with no previous history of cerebrovascular disease and aged over 18 years old.
• Patients with symptomatic cerebrovascular event (stroke, transient ischaemic attack or amaurosis fugax) and image confirmed carotid artery stenosis of >30%. This will include patients scheduled for carotid endarterectomy (>50% for men and >70% for women, by North American Symptomatic Carotid Endarterectomy Trial criteria) or treated conservatively with an optimal medical therapy (if patient declined surgical intervention or is outside surgical criteria for carotid endarterectomy).

Exclusion criteria

• Subjects unable to comply with the study procedures such as a severe disabling stroke.
• Inadequate temporal window for Transcranial Doppler assessment.
• Adults with incapacity.

Trial design

40 participants in 2 patient groups

Healthy Volunteers

Description:

Healthy volunteers with no previous history of cerebrovascular disease and aged over 18 years old.

Treatment:

Diagnostic Test: Transcranial Doppler Ultrasound

Subjects with symptomatic carotid artery stenosis

Description:

Patients with symptomatic cerebrovascular event (stroke, transient ischaemic attack or amaurosis fugax) and image confirmed carotid artery stenosis of \>30%. This will include patients scheduled for carotid endarterectomy (\>50% for men and \>70% for women, by North American Symptomatic Carotid Endarterectomy Trial criteria) or treated conservatively with an optimal medical therapy (if patient declined surgical intervention or is outside surgical criteria for carotid endarterectomy).

Treatment:

Diagnostic Test: Transcranial Doppler Ultrasound