Stroke Clinical Trial
Official title:
Screening Patients Admitted With Stroke or TIA for Carotid Stenosis by Pocked-Sized Ultrasound in Inexperienced Hands and With Novel Doppler Technology
NCT number | NCT02992821 |
Other study ID # | LS_Carot_16 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | July 2018 |
Verified date | March 2023 |
Source | Helse Nord-Trøndelag HF |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | July 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | Department of Medicine, Hospital of Levanger | Levanger | |
Norway | St. Olav University Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Helse Nord-Trøndelag HF | Norwegian University of Science and Technology, St. Olavs Hospital |
Norway,
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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. — View 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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical influence of bed-side ultrasound examinations of the carotid arteries in patients admitted with symptoms of stroke | 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. | The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days | |
Primary | 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 | Reliability of bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners | 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 | The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days | |
Secondary | Proportion of interpretable examinations with bed-side ultrasound examinations of the carotid arteries performed by junior doctors with pocket-sized scanners | 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 | The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days | |
Secondary | Time use of junior doctors performing carotid ultrasound with pocket-sized scanners. | Total time used to record the ultrasound images of the carotid arteries by the junior doctors with pocket-sized ultrasound equipment. | The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days | |
Secondary | Accuracy of high frame rate tracking doppler compared to conventional doppler measurements and computed tomography for grading carotid stenosis. | 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 | The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days |
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