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Pocket-size Cardiovascular Ultrasound in Stroke

Primary Purpose

Ischemic Attack, Transient, Transient Ischemic Attack, Stroke

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Bed-side pocket size ultrasound imaging
GE Ultrasound Vscan
Sponsored by
Helse Nord-Trøndelag HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Attack, Transient focused on measuring Hand-held, Ultrasound, Diagnosis, Cardiovascular, Carotid artery stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • None

Sites / Locations

  • Levanger Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bed-side pocket-size ultrasound

Arm Description

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.

Outcomes

Primary Outcome Measures

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 and the heart after bed-side diagnostic ultrasound by pocket-sized scanner

Secondary Outcome Measures

Reliability of bed-side ultrasound examinations of the carotid arteries and the heart by 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, 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
Feasibility of bed-side ultrasound examinations of the carotid arteries and the heart by pocket-sized scanners
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.

Full Information

First Posted
May 14, 2014
Last Updated
November 5, 2021
Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02141932
Brief Title
Pocket-size Cardiovascular Ultrasound in Stroke
Official Title
Clinical Influence of Pocket-size Ultrasound Examinations of the Carotid Arteries and Heart in Patients Admitted With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Attack, Transient, Transient Ischemic Attack, Stroke, Cerebrovascular Accident, Cerebrovascular Apoplexy, Apoplexy
Keywords
Hand-held, Ultrasound, Diagnosis, Cardiovascular, Carotid artery stenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bed-side pocket-size ultrasound
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bed-side pocket size ultrasound imaging
Intervention Type
Device
Intervention Name(s)
GE Ultrasound Vscan
Primary Outcome Measure Information:
Title
Proportion of patients without need for further diagnostic imaging
Description
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
Time Frame
The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Secondary Outcome Measure Information:
Title
Reliability of bed-side ultrasound examinations of the carotid arteries and the heart by pocket-sized scanners
Description
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
Time Frame
The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Title
Feasibility of bed-side ultrasound examinations of the carotid arteries and the heart by pocket-sized scanners
Description
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.
Time Frame
The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Other Pre-specified Outcome Measures:
Title
Clinical influence of bed-side ultrasound examinations of the carotid arteries and the heart in patients admitted with symptoms of stroke
Description
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.
Time Frame
The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Havard Dalen, M.D., Ph.D.
Organizational Affiliation
Helse Nord-Trøndelag HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levanger Hospital
City
Levanger
ZIP/Postal Code
7601
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20702884
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.
Results Reference
background
PubMed Identifier
24788967
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. Erratum In: Stroke. 2015 Feb;46(2):e54.
Results Reference
background
PubMed Identifier
21127304
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. Erratum In: Stroke. 2011 Feb;42(2):e26.
Results Reference
background
PubMed Identifier
22284252
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.
Results Reference
background
PubMed Identifier
21821611
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.
Results Reference
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Pocket-size Cardiovascular Ultrasound in Stroke

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