Clinical trial NCT02992821: Pocket Sized Carotid Stenosis Screening by Junior Doctors
Official title: Screening Patients Admitted With Stroke or TIA for Carotid Stenosis by Pocked-Sized Ultrasound in Inexperienced Hands and With Novel Doppler Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Attack, Transient
Transient Ischemic Attack
Stroke
Cerebrovascular Accident
Cerebrovascular Apoplexy
Keywords: Hand-held
Ultrasound
Diagnosis
Carotid artery stenosis
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: St. Olavs Hospital
First posted: 2016-12-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Eligibility 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.

Primary outcomes:
measure: Proportion of patients without need for further diagnostic imaging
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Secondary outcomes:
measure: Reliability of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
measure: Proportion of interpretable examinations with bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
measure: Time use of junior doctors performing carotid ultrasound with pocket-sized scanners.
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
measure: Accuracy of high frame rate tracking doppler compared to conventional doppler measurements and computed tomography for grading carotid stenosis.
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Other outcomes:
measure: Clinical influence of bed-side ultrasound examinations of the carotid arteries in patients admitted with symptoms of stroke
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Locations:
city: Levanger
country: Norway
facility: Department of Medicine, Hospital of Levanger
city: Trondheim
country: Norway
facility: St. Olav University Hospital
Study officials:
affiliation: Norwegian University of Science and Tehnology
name: Havard Dalen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.