Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 7:16 AM
Study NCT ID:
NCT02141932
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2014-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pocket-size Cardiovascular Ultrasound in Stroke
Sponsor:
Helse Nord-Trøndelag HF
Organization:
Study Overview
Official Title:
Clinical Influence of Pocket-size Ultrasound Examinations of the Carotid Arteries and Heart in Patients Admitted With Stroke
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: