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Clinical Trials/NCT02992821
NCT02992821
Completed
Not Applicable

Screening Patients Admitted With Stroke or TIA for Carotid Stenosis by Pocked-Sized Ultrasound in Inexperienced Hands and With Novel Doppler Technology

Helse Nord-Trøndelag HF2 sites in 1 country75 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Attack, Transient
Sponsor
Helse Nord-Trøndelag HF
Enrollment
75
Locations
2
Primary Endpoint
Proportion of patients without need for further diagnostic imaging
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Among patients admitted with cerebral ischemia (stroke and transitory ischemic attack (TIA)) it is important to reveal the underlying cause of the disease. In special it is important to reveal if carotid artery stenosis is present as such a finding will directly influence on treatment and follow-up.

For the diagnosis of carotid artery stenosis due to atherosclerosis ultrasound examinations is the cornerstone, but computer tomography and magnetic resonance imaging may be better in some cases. Development of high quality pocket-sized ultrasound scanners has allowed for semi quantitatively bed-side assessment of the carotid arteries and the heart.

The investigators aim to study the feasibility and reliability of bed-side assessment of the carotid arteries by pocket-sized ultrasound scanners in inexperienced hands and the clinical influence of this examination when performed by experienced users.

The investigators hypothesize that a significant proportion of this patient population can be clarified bed-side by junior doctors with no need of further imaging procedures for the assessment of the carotid arteries and the heart.

Detailed Description

Population: Approximately 100 patients admitted to the Department of Medicine, Levanger Hospital and Stroke Department, St. Olavs Hospital with history and findings suspicious of stroke/transitory ischemic attack (TIA). Informed consent mandatory. Exclusion criteria: CT angiography of carotid vessels performed after index event, unless all participating clinicians are fully blinded to the results. Hypotheses: The carotid arteries can be assessed bed-side by pocket-size ultrasound scanners with high feasibility and reliability by junior doctors with limited training. Bed-side assessment of the carotid arteries by pocket-size ultrasound scanners may reduce the need for more advanced (higher cost) imaging procedures. New high frame rate tracking doppler can increase accuracy and reproducability of stenosis grading. Methods: Pocket-size imaging device from GE Ultrasound, commercial available. Approved for clinical use. High-end carotid Doppler ultrasound by high-end equipment (GE Vivid 9) and computer tomography and magnetic resonance imaging at the Department of Radiology, Levanger Hospital and St. Olavs Hospital Verasonics research scanner for high fram rate imaging

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
July 2018
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Admitted to the Department of Medicine with history and findings suspicious of (transient) cerebrovascular ischemia and willing and able to give their informed written consent

Exclusion Criteria

  • Evaluation of carotid artery stenosis by imaging (CT, MRI or ultrasound) performed during the stay prior to inclusion.

Outcomes

Primary Outcomes

Proportion of patients without need for further diagnostic imaging

Time Frame: The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days

Proportion of patients which is not in need of further imaging procedures of the carotid arteries after bed-side diagnostic ultrasound performed by junior doctors with with pocket-sized scanner

Secondary Outcomes

  • Reliability of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners(The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days)
  • Proportion of interpretable examinations with bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners(The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days)
  • Time use of junior doctors performing carotid ultrasound with pocket-sized scanners.(The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days)
  • Accuracy of high frame rate tracking doppler compared to conventional doppler measurements and computed tomography for grading carotid stenosis.(The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days)

Study Sites (2)

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