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Completed

NCT Number: NCT02141932

Pocket-size Cardiovascular Ultrasound in Stroke

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.

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Key information

Conditions

Ischemic Attack, Transient Apoplexy 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

Levanger Hospital

Levanger, 7601, Norway

About this study

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.

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

  • None

Treatment and study plan

Bed-side pocket size ultrasound imaging

Procedure

GE Ultrasound Vscan

Device

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 and the heart after bed-side diagnostic ultrasound by pocket-sized scanner

Secondary outcomes

  1. Reliability of bed-side ultrasound examinations of the carotid arteries and the heart by 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, 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

  2. Feasibility of bed-side ultrasound examinations of the carotid arteries and the heart by pocket-sized scanners

    Time frame: 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.

Other outcomes

  1. Clinical influence of bed-side ultrasound examinations of the carotid arteries and the heart 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

Registry information

Official study title

Clinical Influence of Pocket-size Ultrasound Examinations of the Carotid Arteries and Heart in Patients Admitted With Stroke

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 20, 2014
Registry last updated
Nov 9, 2021

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.

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