Ignite Creation Date:
2024-05-06 @ 8:27 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02748941
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2016-04-11
Brief Title:
Carotid Atherosclerosis Innovative Imaging Biomarkers Study Case-control
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
None
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ACABII
Brief Summary:
Cerebrovascular accident CVA constitutes a major health public problem This represents the second cardiovascular death cause CVA is ischemic in 80 of cases Atheroma of large arteries mainly carotid is involved in about 20 of cases
After several high grade studies NASCET ECST ACAS ACST carotid surgery is based on stenosis calculation by Doppler ultrasound CT angiography MRI angiography or arteriography
The composition of the plaque showing its vulnerability is associated with embolic risk and stroke The therapeutic strategy based only on the narrowing of the arterial lumen is not satisfactory enough to prevent the occurrence of a transient ischemic attack TIA or an ipsilateral stroke due to carotid stenosis Thus new techniques emerge to evaluate in vivo the inflammation of the plaque its embolic consequences or the mechanical stress it undergoes These techniques are High Resolution MRI HR MRI evaluation of the Gray Scale Median GSM level study of the plaque vascularization with Contrast Enhanced ultrasound CEUS High Intensity Transient Signals HITS by transcranial Doppler micro RNA profile mi RNA These different modalities must be combined in order to increase the efficiency
Based on these encouraging results the investigator aim at evaluating the ability of different methods or their combination to predict the occurrence of ischemic stroke or TIA due to emboli from a carotid atherosclerotic plaque Before considering a cohort study he investigator want to evaluate the performance of each of these new methods in the characterization of carotid plaque instability Performance evaluation will allow us to choose secondarily the most relevant association
The investigator propose as a first step to make a case-control study with these methods the cases are patients who had an ischemic stroke authenticated by both the clinical exam and brain MRI on the same side as the carotid stenosis and the controls are patients with carotid stenosis but without ischemic stroke This study is a cross-sectional study because it simultaneously measures the occurrence of the event ischemic stroke and the characteristics of the atheromatous plaque
Over a 2 year period 45 symptomatic patients and 105 asymptomatic patients will be included with a carotid stenosis with at least a 50 caliber constriction according to NASCET criteria North American Symptomatic Carotid Endarterectomy Trial
After several high grade studies NASCET ECST ACAS ACST carotid surgery is based on stenosis calculation by Doppler ultrasound CT angiography MRI angiography or arteriography
The composition of the plaque showing its vulnerability is associated with embolic risk and stroke The therapeutic strategy based only on the narrowing of the arterial lumen is not satisfactory enough to prevent the occurrence of a transient ischemic attack TIA or an ipsilateral stroke due to carotid stenosis Thus new techniques emerge to evaluate in vivo the inflammation of the plaque its embolic consequences or the mechanical stress it undergoes These techniques are High Resolution MRI HR MRI evaluation of the Gray Scale Median GSM level study of the plaque vascularization with Contrast Enhanced ultrasound CEUS High Intensity Transient Signals HITS by transcranial Doppler micro RNA profile mi RNA These different modalities must be combined in order to increase the efficiency
Based on these encouraging results the investigator aim at evaluating the ability of different methods or their combination to predict the occurrence of ischemic stroke or TIA due to emboli from a carotid atherosclerotic plaque Before considering a cohort study he investigator want to evaluate the performance of each of these new methods in the characterization of carotid plaque instability Performance evaluation will allow us to choose secondarily the most relevant association
The investigator propose as a first step to make a case-control study with these methods the cases are patients who had an ischemic stroke authenticated by both the clinical exam and brain MRI on the same side as the carotid stenosis and the controls are patients with carotid stenosis but without ischemic stroke This study is a cross-sectional study because it simultaneously measures the occurrence of the event ischemic stroke and the characteristics of the atheromatous plaque
Over a 2 year period 45 symptomatic patients and 105 asymptomatic patients will be included with a carotid stenosis with at least a 50 caliber constriction according to NASCET criteria North American Symptomatic Carotid Endarterectomy Trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None