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Trial record 27 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

Pocket Sized Carotid Stenosis Screening by Junior Doctors

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ClinicalTrials.gov Identifier: NCT02992821
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
Norwegian University of Science and Technology
St. Olavs Hospital
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 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.


Condition or disease Intervention/treatment Phase
Ischemic Attack, Transient Transient Ischemic Attack Stroke Cerebrovascular Accident Cerebrovascular Apoplexy Procedure: Bed-side pocket size ultrasound imaging Procedure: High frame rate tracking doppler Not Applicable

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Screening Patients Admitted With Stroke or TIA for Carotid Stenosis by Pocked-Sized Ultrasound in Inexperienced Hands and With Novel Doppler Technology
Actual Study Start Date : December 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

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 by junior doctors. All participants will then be examined by reference imaging in specific ultrasound laboratories with conventional high end equipment and new doppler techniques and when appropriate computer tomography or magnetic resonance imaging.
Procedure: Bed-side pocket size ultrasound imaging
Other Name: GE Ultrasound V-scan Duo probe

Procedure: High frame rate tracking doppler
Other Name: Verasonics research scanner




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 after bed-side diagnostic ultrasound performed by junior doctors with with pocket-sized scanner


Secondary Outcome Measures :
  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 Outcome Measures:
  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.



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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:

  • Evaluation of carotid artery stenosis by imaging (CT, MRI or ultrasound) performed during the stay prior to inclusion.

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): NCT02992821


Contacts
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Contact: Havard Dalen, MD, PhD 95871716 ext 0047 havard.dalen@ntnu.no
Contact: Torbjorn Graven, MD 74098206 ext 0047 tgraven@hnt.no

Locations
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Norway
Department of Medicine, Hospital of Levanger Recruiting
Levanger, Norway, 7600
Contact: Havard Dalen, MD    +47 740 98 000    havard.dalen@hnt.no   
Contact: Torbjorn Graven, MD    +47 740 98 000    TGraven@hnt.no   
Principal Investigator: Havard Dalen, MD         
St. Olav University Hospital Recruiting
Trondheim, Norway, 7491
Contact: Espen Holte, MD    06800 ext 0047    espen.holte@stolav.no   
Contact: Lars Saxhaug, MD    97099991 ext 0047    lars.molgaard.saxhaug@ntnu.no   
Sponsors and Collaborators
Levanger Hospital
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Principal Investigator: Havard Dalen, MD, PhD Norwegian University of Science and Tehnology

Publications:

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Responsible Party: Havard Dalen, Consultant, Assistant Professor, Levanger Hospital
ClinicalTrials.gov Identifier: NCT02992821     History of Changes
Other Study ID Numbers: LS_Carot_16
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Depending on university's progress for IPD

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

Additional relevant MeSH terms:
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Carotid Stenosis
Stroke
Ischemia
Constriction, Pathologic
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Brain Ischemia
Carotid Artery Diseases
Arterial Occlusive Diseases