Pocket-size Cardiovascular Ultrasound in Stroke

Completed

Phase N/A Results N/A

Trial Description

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 and the heart by pocket-sized ultrasound scanners 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 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 with history and findings suspicious of stroke/transitory ischemic attack (TIA). Informed consent mandatory.
No exclusion criteria.
Hypotheses:
The carotid arteries and the heart can be assessed bed-side by pocket-size ultrasound scanners with high feasibility and reliability.
Bed-side assessment of the carotid arteries and the heart by pocket-size ultrasound scanners may reduce the need for more advanced (higher cost) imaging procedures.
Methods:
Pocket-size imaging device from GE Ultrasound, commercial available. Approved for clinical use. High-end echocardiography and carotid Doppler ultrasound by high-end equipment (GE Vivid 9) and computer tomography and magnetic resonance imaging at the Department of Radiology, Levanger Hospital.

Conditions

Interventions

  • Bed-side pocket size ultrasound imaging Procedure
    Other Names: GE Ultrasound V-scan Duo probe
    ARM 1: Kind: Experimental
    Label: Bed-side pocket-size ultrasound
    Description: All participants will be examined bed-side by pocket size ultrasound for the assessment of the carotid arteries and the heart. All participants will then be examined by reference imaging in specific ultrasound laboratories and when appropriate computer tomography or magnetic resonance imaging.
  • GE Ultrasound Vscan Device
    ARM 1: Kind: Experimental
    Label: Bed-side pocket-size ultrasound
    Description: All participants will be examined bed-side by pocket size ultrasound for the assessment of the carotid arteries and the heart. All participants will then be examined by reference imaging in specific ultrasound laboratories and when appropriate computer tomography or magnetic resonance imaging.

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients without need for further diagnostic imaging The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days No
Secondary Reliability of bed-side ultrasound examinations of the carotid arteries and the heart by pocket-sized scanners The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days Yes
Secondary Feasibility of bed-side ultrasound examinations of the carotid arteries and the heart by pocket-sized scanners The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days Yes

Sponsors