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Pocket-size Cardiovascular Ultrasound in Stroke

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ClinicalTrials.gov Identifier: NCT02141932
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : January 12, 2016
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Havard Dalen, Levanger Hospital

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.


Condition or disease Intervention/treatment Phase
Ischemic Attack, Transient Transient Ischemic Attack Stroke Cerebrovascular Accident Cerebrovascular Apoplexy Apoplexy Procedure: Bed-side pocket size ultrasound imaging Device: GE Ultrasound Vscan Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Influence of Pocket-size Ultrasound Examinations of the Carotid Arteries and Heart in Patients Admitted With Stroke
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bed-side pocket-size ultrasound
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.
Procedure: Bed-side pocket size ultrasound imaging
Device: GE Ultrasound Vscan



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141932


Locations
Norway
Levanger Hospital
Levanger, Norway, 7601
Sponsors and Collaborators
Levanger Hospital
Norwegian University of Science and Technology
Investigators
Principal Investigator: Havard Dalen, M.D., Ph.D. Levanger Hospital

Publications:

Responsible Party: Havard Dalen, Consultant, Researcher, Levanger Hospital
ClinicalTrials.gov Identifier: NCT02141932     History of Changes
Other Study ID Numbers: LH_Card2014-1
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Havard Dalen, Levanger Hospital:
Hand-held
Ultrasound
Diagnosis
Cardiovascular
Carotid artery stenosis

Additional relevant MeSH terms:
Stroke
Ischemia
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia