Reproducibility Study of Transcranial Doppler

NCT ID: NCT03050567

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-17
• Study Completion Date: 2017-08-09

Brief 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.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Volunteers

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

Transcranial Doppler Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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).

Subjects with symptomatic carotid artery stenosis

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).

Transcranial Doppler Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Cardiovascular Science

Edinburgh, , United Kingdom

Countries

United Kingdom

References

Kaczynski J, Home R, Shields K, Walters M, Whiteley W, Wardlaw J, Newby DE. Reproducibility of Transcranial Doppler ultrasound in the middle cerebral artery. Cardiovasc Ultrasound. 2018 Sep 11;16(1):15. doi: 10.1186/s12947-018-0133-z.

Reference Type: DERIVED

PMID: 30200977 (View on PubMed)

Other Identifiers

AC16131

Identifier Type: -

Identifier Source: org_study_id