Pocket Sized Carotid Stenosis Screening by Junior Doctors

Helse Nord-Trøndelag HF

Status: Completed

Conditions: Cerebrovascular Accident; Ischemic Attack, Transient; Stroke; Cerebrovascular Apoplexy; Transient Ischemic Attack

Treatments: Procedure: High frame rate tracking doppler; Procedure: Bed-side pocket size ultrasound imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02992821

LS_Carot_16

Details and patient eligibility

About

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.

Full 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

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Bed-side pocket-size ultrasound

Experimental group

Description:

All participants will be examined bed-side by pocket size ultrasound for the assessment of the carotid arteries by junior doctors. All participants will then be examined by reference imaging in specific ultrasound laboratories with conventional high end equipment and new doppler techniques and when appropriate computer tomography or magnetic resonance imaging.

Treatment:

Procedure: Bed-side pocket size ultrasound imaging

Procedure: High frame rate tracking doppler