Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05218421
Status:
UNKNOWN
Last Update Posted:
2022-02-01
First Post:
2022-01-20
Brief Title:
Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
NOT_YET_RECRUITING
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:
CAP-VALUE
Brief Summary:
Objective To explore the association between spatio-temporal blood flow velocities peak systole and end-diastole at prior-stenosis at maximum stenosis and post-stenosis and carotid plaque vulnerability defined by histology staining Secondary to assess the association between ultrasound elastography and carotid plaque vulnerability defined by histology staining Furthermore to assess the association between blood flow-derived parameters including wall shear stress WSS vector complexity and vorticity and plaque vulnerability To evaluate the hemodynamic consequences of a CEA Last to explore whether the presence of circulating biomarkers is related to the degree of plaque vulnerability as reflected by histology andor ultrasound
Study design A multicentre prospective observational cohort study in a total of 70 patients
Study population Patients with a carotid artery stenosis 50 according to clinically performed imaging ie duplex computed tomography angiography CTA or magnetic resonance angiography MRA that are scheduled for a CEA
Intervention observational A carotid ultrasound with flow and elastography strain and shear wave measurements will be performed maximally 2 weeks prior to the CEA In the first 20 included patients in the Radboudumc a 10 mL blood sample will be collected during surgery via the arterial line that is applied for regular care The plaque excised during CEA will be histologically examined to assess the plaque composition and therefore plaque vulnerability Ultrasound-based flow imaging will be repeated six weeks after the CEA to assess the hemodynamic consequences of the CEA procedure Besides clinical parameters will be subtracted from electronic health record or if missing anamnestically collected from the patient
Main study parametersendpoints Association between 2D spatio-temporal blood flow velocities peak systole and end-diastole at prior-stenosis maximum stenosis and post-stenosis measured by ultrafast ultrasound measurements and plaque vulnerability stable versus unstable defined by histology staining
Study design A multicentre prospective observational cohort study in a total of 70 patients
Study population Patients with a carotid artery stenosis 50 according to clinically performed imaging ie duplex computed tomography angiography CTA or magnetic resonance angiography MRA that are scheduled for a CEA
Intervention observational A carotid ultrasound with flow and elastography strain and shear wave measurements will be performed maximally 2 weeks prior to the CEA In the first 20 included patients in the Radboudumc a 10 mL blood sample will be collected during surgery via the arterial line that is applied for regular care The plaque excised during CEA will be histologically examined to assess the plaque composition and therefore plaque vulnerability Ultrasound-based flow imaging will be repeated six weeks after the CEA to assess the hemodynamic consequences of the CEA procedure Besides clinical parameters will be subtracted from electronic health record or if missing anamnestically collected from the patient
Main study parametersendpoints Association between 2D spatio-temporal blood flow velocities peak systole and end-diastole at prior-stenosis maximum stenosis and post-stenosis measured by ultrafast ultrasound measurements and plaque vulnerability stable versus unstable defined by histology staining
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None