Reproducibility Study of Transcranial Doppler

Stroke Clinical Trial

Official title:

Reproducibility Study of Transcranial Doppler Microembolic Signals Detection in the Middle Cerebral Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050567
• Other study ID #: AC16131
• Status: Completed
• Start date: March 17, 2017
• Est. completion date: August 9, 2017

Study information

• Verified date: May 2017
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 9, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Diagnostic Test:
• Transcranial Doppler Ultrasound
Transcranial Doppler will be performed on the symptomatic (ipsilateral to an index event) middle cerebral artery in a quiet temperature controlled room. The middle cerebral artery will be identified through the temporal window in a supine position with a flow direction towards the probe. The subject will have a head frame (Marc 600 Spencer Technologies, USA) fitted to reduce motion and to secure a constant angle of the middle cerebral artery insonation depth at 50-60 mm from the skull surface. All recordings will be made using the ST3 Transcranial Doppler Ultrasound System (Spencer Technologies, USA) with a 2-MHz transducer for 1 hour. Emboli will be detected by listening for their characteristic short audible sound (range 10-100 ms, intensity threshold above 7 dB) and spectral appearance using the International Consensus Group microembolus identification criteria and an automated Embolus Detection Software (Spencer Technologies, USA).

Locations

Country	Name	City	State
United Kingdom	Centre for Cardiovascular Science	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of microembolic signals in the Middle Cerebral Artery.		14 days