Pocket-size Cardiovascular Ultrasound in Stroke

Not Applicable

Completed

• Conditions: Apoplexy; Stroke; Cerebrovascular Accident; Transient Ischemic Attack; Cerebrovascular Apoplexy; Ischemic Attack, Transient
• Interventions: Procedure: Bed-side pocket size ultrasound imaging; Device: GE Ultrasound Vscan

• Registration Number: NCT02141932
• Lead Sponsor: Helse Nord-Trøndelag HF

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 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.

Study Timeline

• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Study Start: 2014-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bed-side pocket-size ultrasound	Bed-side pocket size ultrasound imaging	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.
Bed-side pocket-size ultrasound	GE Ultrasound Vscan	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.

Primary Outcome Measures

Name	Time	Method
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	Proportion of patients which is not in need of further imaging procedures of the carotid arteries and the heart after bed-side diagnostic ultrasound by pocket-sized scanner

Secondary Outcome Measures

Name	Time	Method
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	The accuracy of semi quantitatively classifications (like i.e. non-significant atherosclerosis of the carotid arteries vs significant stenosis of the carotid arteries, as well as semi quantitatively classification of left ventricular regional and global function, valvular function, intra atrial septum morphology) of bed-side ultrasound examinations of the carotid arteries and the heart by pocket-sized scanners compared with reference methods
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	Feasibility of bed-side ultrasound examinations of the carotid arteries and the heart by pocket-sized scanners compared with reference imaging methods. Feasibility 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, left ventricular regional and global function, valvular (in special mitral and aortic valve) morphology and function, intra atrial septum morphology with respect to shunts, great vessels with respect to atherosclerosis. The common path for relevant cardiac structures and functions to test is the relation to formation of thrombus.

Trial Locations

Locations (1)

Levanger Hospital; 🇳🇴 Levanger, Norway