- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03050567
Reproducibility Study of Transcranial Doppler
Reproducibility Study of Transcranial Doppler Microembolic Signals Detection in the Middle Cerebral Artery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Edinburgh, United Kingdom, EH16 4SB
- Centre for Cardiovascular Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Two cohorts of subjects including healthy volunteers and those with symptomatic carotid artery stenosis will be recruited in different ways. All subjects will undergo basic clinical evaluation prior to participation. In the second cohort, this will include assessment of relevant carotid artery and brain imaging investigations as well.
Healthy volunteers will be recruited from the Centre for Cardiovascular Science at Edinburgh University by the Primary Investigator (PI).
Patients with evidence of an acute neurovascular event (stroke, transient ischaemic attach and retinal ischaemia) due to a symptomatic carotid artery stenosis will be recruited from the acute TIA/Stroke clinics and inpatients at Edinburgh Royal Infirmary by the responsible Consultant Neurologist or Stroke Physician. Once eligible patients are identified at this point PI will recruit subjects into the study.
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Volunteers
Healthy volunteers with no previous history of cerebrovascular disease and aged over 18 years old.
|
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 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence of microembolic signals in the Middle Cerebral Artery.
Time Frame: 14 days
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14 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AC16131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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