Skip to main content
OpenTrials
Completed

NCT Number: NCT02992821

Pocket Sized Carotid Stenosis Screening by Junior Doctors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemic Attack, Transient Arterial Occlusive Diseases Brain Diseases Brain Ischemia Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Apoplexy Cerebrovascular Disorders Disease Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Transient Ischemic Attack Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Hospital of Levanger, Levanger, Norway

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bed-side pocket size ultrasound imaging

Procedure

Other names: GE Ultrasound V-scan Duo probe

High frame rate tracking doppler

Procedure

Other names: Verasonics research scanner

Primary outcomes

  1. 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

  1. Reliability of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners

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

    The accuracy of semi quantitatively classifications (like i.e. non-significant atherosclerosis of the carotid arteries vs significant stenosis of the carotid arteries) of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners compared with reference methods performed by experienced personnel

  2. Proportion of interpretable examinations with bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners

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

    Proportion of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners of sufficient quality compared with reference imaging methods. Quality includes both to what extent the specific structure can be completely assessed, and to what degree the recordings can be interpreted by the operator. Structures and specific functions to be tested: carotid arteries with respect to degree of atherosclerosis and stenosis

  3. Time use of junior doctors performing carotid ultrasound with pocket-sized scanners.

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

    Total time used to record the ultrasound images of the carotid arteries by the junior doctors with pocket-sized ultrasound equipment.

  4. Accuracy of high frame rate tracking doppler compared to conventional doppler measurements and computed tomography for grading carotid stenosis.

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

    Accuracy of velocity measurements with high frame rate tracking doppler for judging degree of stenosis compared to conventional pulsed wave doppler and computed tomography angiography

Other outcomes

  1. Clinical influence of bed-side ultrasound examinations of the carotid arteries in patients admitted with symptoms of stroke

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

    In addition to what described in the primary measure it will be of interest to study predictors of clinical influence of different patient characteristics as age, sex, history, anatomic localization of the vascular event, medication, heart rhythms, ECG findings). Furthermore, the influence on the total cost will be studied.

Sponsors and collaborators

Lead sponsor

Helse Nord-Trøndelag HF

Other

Collaborators

  • Norwegian University of Science and Technology
  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2016
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.