Ignite Creation Date:
2024-05-06 @ 8:21 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02719652
Status:
UNKNOWN
Last Update Posted:
2016-08-04
First Post:
2016-03-16
Brief Title:
Vessel Wall and Perfusion Imaging in Intracranial Atherosclerosis
Sponsor:
Xiuhai Guo
Organization:
Capital Medical University
Study Overview
Official Title:
Vessel Wall and Perfusion Imaging in Intracranial Atherosclerosis
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
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:
None
Brief Summary:
Intracranial atherosclerotic disease ICAD is an important cause of ischemic stroke The occurrence of stroke caused by symptomatic ICAD is significantly different compared with asymptomatic ICAD 19 vs 35 suggesting that plaque vulnerability may be responsible for the difference Based on the previous high-resolution magnetic resonance vessel wall imaging HR-MRI results the investigators hypothesis that the feature of intracranial plaque enhancement is an important imaging biomarker of plaque instability which is closely related to stroke The investigators will establish the ICAD cohort and use HR-MRI to investigate the composition morphology and the enhancement pattern of symptomatic ICAD plaques These findings will correlate with biochemical markers and stroke recurrence in order to explore
1 plaque characteristics and the enhancement features between symptomatic ICAD and asymptomatic ICAD
2 the relationship between plaque enhancement and the composition of plaques
3 relationship among enhancement features of symptomatic ICAD plaques biomarkers with different clinical significance
4 evolution of enhancement features of symptomatic ICAD plaques under intensive medical therapy
The investigators aim to explore the correlation between vulnerable plaque stratification and clinical outcomes to explore the value of vascular responses in the pathogenicity of ICAD vulnerable plaques as well as to provide objective basis for the establishment of the evaluation criteria of intracranial atherosclerotic vulnerable plaques
1 plaque characteristics and the enhancement features between symptomatic ICAD and asymptomatic ICAD
2 the relationship between plaque enhancement and the composition of plaques
3 relationship among enhancement features of symptomatic ICAD plaques biomarkers with different clinical significance
4 evolution of enhancement features of symptomatic ICAD plaques under intensive medical therapy
The investigators aim to explore the correlation between vulnerable plaque stratification and clinical outcomes to explore the value of vascular responses in the pathogenicity of ICAD vulnerable plaques as well as to provide objective basis for the establishment of the evaluation criteria of intracranial atherosclerotic vulnerable plaques
Detailed Description:
Detailed description
Title Vessel wall and Perfusion Imaging in Intracranial Atherosclerosis
Design This is an prospective study that will study the characteristics of intracranial atherosclerotic plaque and the enhancement features of symptomatic ICAD during a mean follow-up of 1 year in symptomatic or asymtomatic patients with moderate to severe stenosis of middle cerebral arteryMCA
In the WASID trailpatients with at least 70 stenosis of a major intracranial artery had an increased risk of recurrent stroke HoweverThe degree of stenosis is no longer the single predictor of vulnerable atherosclerotic lesions Vulnerable plaques are closely associated with stroke recurrenceWith the development of neurologic imaging HR-MRI has unique ability to provide information on plaque compositions plaque burden and vulnerable features Several recent investigations suggest that enhancement of intracranial plaque is associated with recurrent stroke However no corhort study has been performed
This prospective multicenter trail will be conducted in China Based on the previous workparticipants will be divided into two groups symtomatic ICAD and asymtomatic ICAD Neurological examination and clinical sera testing will be performed at baseline 1 month 3 months 6 months and 12 monthsThe stroke incidence rate of asymptomatic ICAD and stroke recurrence rate of symptomatic ICAD will be recorded
Title Vessel wall and Perfusion Imaging in Intracranial Atherosclerosis
Design This is an prospective study that will study the characteristics of intracranial atherosclerotic plaque and the enhancement features of symptomatic ICAD during a mean follow-up of 1 year in symptomatic or asymtomatic patients with moderate to severe stenosis of middle cerebral arteryMCA
In the WASID trailpatients with at least 70 stenosis of a major intracranial artery had an increased risk of recurrent stroke HoweverThe degree of stenosis is no longer the single predictor of vulnerable atherosclerotic lesions Vulnerable plaques are closely associated with stroke recurrenceWith the development of neurologic imaging HR-MRI has unique ability to provide information on plaque compositions plaque burden and vulnerable features Several recent investigations suggest that enhancement of intracranial plaque is associated with recurrent stroke However no corhort study has been performed
This prospective multicenter trail will be conducted in China Based on the previous workparticipants will be divided into two groups symtomatic ICAD and asymtomatic ICAD Neurological examination and clinical sera testing will be performed at baseline 1 month 3 months 6 months and 12 monthsThe stroke incidence rate of asymptomatic ICAD and stroke recurrence rate of symptomatic ICAD will be recorded
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