Pocket Sized Carotid Stenosis Screening by Junior Doctors

NCT02992821 | Completed

• 1 other identifier: LS_Carot_16
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Attack, Transient; Transient Ischemic Attack; Stroke; Cerebrovascular Accident; Cerebrovascular Apoplexy

Keywords

Hand-held; Ultrasound; Diagnosis; Carotid artery stenosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients without need for further diagnostic imaging

  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

  The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days

Secondary Outcomes (4)

• Reliability of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners

  The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days

• Proportion of interpretable examinations with bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners

  The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days

• Time use of junior doctors performing carotid ultrasound with pocket-sized scanners.

  The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days

• Accuracy of high frame rate tracking doppler compared to conventional doppler measurements and computed tomography for grading carotid stenosis.

  The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days

Other Outcomes (1)

• Clinical influence of bed-side ultrasound examinations of the carotid arteries in patients admitted with symptoms of stroke

  The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days

Study Arms (1)

Bed-side pocket-size ultrasound

EXPERIMENTAL

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; Procedure: High frame rate tracking doppler

Interventions

Bed-side pocket size ultrasound imaging PROCEDURE

Also known as: GE Ultrasound V-scan Duo probe

Bed-side pocket-size ultrasound

High frame rate tracking doppler PROCEDURE

Also known as: Verasonics research scanner

Bed-side pocket-size ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Helse Nord-Trøndelag HF: lead
• Norwegian University of Science and Technology: collaborator
• St. Olavs Hospital: collaborator

Study Sites (2)

Department of Medicine, Hospital of Levanger

Levanger, 7600, Norway

Location

St. Olav University Hospital

Trondheim, 7491, Norway

Location

Related Publications (6)

• Pepi M, Evangelista A, Nihoyannopoulos P, Flachskampf FA, Athanassopoulos G, Colonna P, Habib G, Ringelstein EB, Sicari R, Zamorano JL, Sitges M, Caso P; European Association of Echocardiography. Recommendations for echocardiography use in the diagnosis and management of cardiac sources of embolism: European Association of Echocardiography (EAE) (a registered branch of the ESC). Eur J Echocardiogr. 2010 Jul;11(6):461-76. doi: 10.1093/ejechocard/jeq045.

  PMID: 20702884 BACKGROUND

• Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.

  PMID: 24788967 BACKGROUND

• Goldstein LB, Bushnell CD, Adams RJ, Appel LJ, Braun LT, Chaturvedi S, Creager MA, Culebras A, Eckel RH, Hart RG, Hinchey JA, Howard VJ, Jauch EC, Levine SR, Meschia JF, Moore WS, Nixon JV, Pearson TA; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Epidemiology and Prevention; Council for High Blood Pressure Research,; Council on Peripheral Vascular Disease, and Interdisciplinary Council on Quality of Care and Outcomes Research. Guidelines for the primary prevention of stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011 Feb;42(2):517-84. doi: 10.1161/STR.0b013e3181fcb238. Epub 2010 Dec 2.

  PMID: 21127304 BACKGROUND

• Mjolstad OC, Dalen H, Graven T, Kleinau JO, Salvesen O, Haugen BO. Routinely adding ultrasound examinations by pocket-sized ultrasound devices improves inpatient diagnostics in a medical department. Eur J Intern Med. 2012 Mar;23(2):185-91. doi: 10.1016/j.ejim.2011.10.009. Epub 2011 Nov 9.

  PMID: 22284252 BACKGROUND

• Skjetne K, Graven T, Haugen BO, Salvesen O, Kleinau JO, Dalen H. Diagnostic influence of cardiovascular screening by pocket-size ultrasound in a cardiac unit. Eur J Echocardiogr. 2011 Oct;12(10):737-43. doi: 10.1093/ejechocard/jer111. Epub 2011 Aug 4.

  PMID: 21821611 BACKGROUND

• Fredriksen TD, Avdal J, Ekroll IK, Dahl T, Lovstakken L, Torp H. Investigations of spectral resolution and angle dependency in a 2-D tracking Doppler method. IEEE Trans Ultrason Ferroelectr Freq Control. 2014 Jul;61(7):1161-70. doi: 10.1109/TUFFC.2014.3015.

  PMID: 24960705 BACKGROUND

MeSH Terms

Conditions

Ischemic Attack, Transient; Stroke; Disease; Carotid Stenosis

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carotid Artery Diseases; Arterial Occlusive Diseases

Study Officials

• Havard Dalen, MD, PhD

  Norwegian University of Science and Tehnology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

NO (2)