Ischemic Attack, TransientNCT02992821
Pocket Sized Carotid Stenosis Screening by Junior Doctors
A study testing Bed-side pocket size ultrasound imaging and High frame rate tracking doppler in people with Ischemic Attack, Transient and Transient Ischemic Attack, run by Helse Nord-Trøndelag HF at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Attack, Transient, Transient Ischemic Attack, Stroke
- What is being tested?
- Bed-side pocket size ultrasound imaging and High frame rate tracking doppler
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesNorway
- Study dates
- Dec 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Evaluation of carotid artery stenosis by imaging (CT, MRI or ultrasound) performed during the stay prior to inclusion.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of Medicine, Hospital of Levanger
Levanger, 7600
St. Olav University Hospital
Trondheim, 7491
About this study
Official title: Screening Patients Admitted With Stroke or TIA for Carotid Stenosis by Pocked-Sized Ultrasound in Inexperienced Hands and With Novel Doppler Technology
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.
Read more
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.
Read the 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
- Conditions
- Ischemic Attack, Transient, Transient Ischemic Attack, Stroke, Cerebrovascular Accident, Cerebrovascular Apoplexy
- Being tested
- Bed-side pocket size ultrasound imaging, High frame rate tracking doppler
- Keywords
- Hand-held, Ultrasound, Diagnosis, Carotid artery stenosis
- Medical subject headings
- Ischemic Attack, Transient, Stroke, Disease, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed-side pocket size ultrasound imagingProcedure or surgery
Also called GE Ultrasound V-scan Duo probe
High frame rate tracking dopplerProcedure or surgery
Also called Verasonics research scanner
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bed-side pocket size ultrasound imaging; Procedure: High frame rate tracking doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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
Measured: 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
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
Measured: 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.
Total time used to record the ultrasound images of the carotid arteries by the junior doctors with pocket-sized ultrasound equipment.
Measured: 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.
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
Measured: The participants will be followed for the duration of hospital stay, an expected average of approximately 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ischemic Attack, TransientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Havard Dalen, MD, PhD, Principal investigator, Norwegian University of Science and Tehnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992821
- Sponsor's protocol ID
- LS_Carot_16
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2016
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Depending on university's progress for IPD
Publications
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.
PubMed 20702884Kernan 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.
PubMed 24788967Goldstein 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.
PubMed 21127304Mjolstad 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.
PubMed 22284252Skjetne 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.
PubMed 21821611Fredriksen 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.
PubMed 24960705
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Patients Admitted With Stroke or TIA for Carotid Stenosis by Pocked-Sized Ultrasound in Inexperienced Hands and With Novel Doppler Technology
- ClinicalTrials.gov ID
- NCT02992821
- Acronym / sponsor ID
- LS_Carot_16
- Conditions
- Ischemic Attack, Transient, Transient Ischemic Attack, Stroke, Cerebrovascular Accident, Cerebrovascular Apoplexy
- Keywords
- Hand-held, Ultrasound, Diagnosis, Carotid artery stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, St. Olavs Hospital
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bed-side pocket-size ultrasound | Experimental | Procedure: Bed-side pocket size ultrasound imaging, Procedure: High frame rate tracking dopplerAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Evaluation of carotid artery stenosis by imaging (CT, MRI or ultrasound) performed during the stay prior to inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bed-side pocket size ultrasound imagingAlso: GE Ultrasound V-scan Duo probe | Procedure or surgery | Bed-side pocket-size ultrasound |
| High frame rate tracking dopplerAlso: Verasonics research scanner | Procedure or surgery | Bed-side pocket-size ultrasound |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Background: PubMed 20702884Pepi 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.
- Background: PubMed 24788967Kernan 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.
- Background: PubMed 21127304Goldstein 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.
- Background: PubMed 22284252Mjolstad 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.
- Background: PubMed 21821611Skjetne 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.
- Background: PubMed 24960705Fredriksen 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.
- Individual participant dataSharing planned: Undecided. Depending on university's progress for IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Havard Dalen, MD, PhD principal investigator
Norwegian University of Science and Tehnology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed-side pocket size ultrasound imaging and High frame rate tracking doppler in people with Ischemic Attack, Transient and Transient Ischemic Attack, run by Helse Nord-Trøndelag HF at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02992821, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.