Ignite Creation Date:
2024-05-05 @ 11:53 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01440296
Status:
UNKNOWN
Last Update Posted:
2011-09-26
First Post:
2011-09-22
Brief Title:
Magnetic Resonance Imaging MRI Characterization of Carotid Plaque and Prediction of End-organ and Clinical Outcomes
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Magnetic Resonance Imaging MRI Characterization of Carotid Plaque and Prediction of End-organ and Clinical Outcomes
Status:
UNKNOWN
Status Verified Date:
2011-09
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:
The Canadian Atherosclerosis Imaging Network CAIN is a pan-canadian imaging network funded through grants from the Canadian Foundation for Innovation CFI and the Canadian Institutes of Health Research CIHR This unique research network is focused on the pathobiology of atherosclerotic disease as it pertains to the coronary and carotid circulations The CAIN research program involves the creation of a unique national network focused on in vivo imaging of vessel wall disease combined with imaging of occult end-organ disease as well as the acquisition of clinical and pathological end points CAIN enables unprecedented cross-sectional and longitudinal clinical studies of patients with atherosclerotic disease in coronary or carotid vascular beds and has established an international resource for studying the natural history progression regression and novel therapeutic interventions aimed at atherosclerosis
The primary outcome of this study is to accurately characterise carotid plaque morphology in non-surgical patients with mild to severe 30-95 carotid disease The investigators will also assess evidence of ischaemic brain disease Patients will undergo MRI scanning of the brain and carotid and US scanning of the carotid at baseline and thereafter at 1 and 2 years or sooner if presenting clinically in order to monitor the natural history of carotid atherosclerosis and its effect on end-organ brain disease
Patients will consent to baseline scanning and follow up at 1 and 2 years and databasing of clinical and imaging data After each imaging session images will be processed stored locally and also sent to a central repository 500 patients will be recruited over a 2 year period in anticipation of study completion within 4 years
The primary outcome of this study is to accurately characterise carotid plaque morphology in non-surgical patients with mild to severe 30-95 carotid disease The investigators will also assess evidence of ischaemic brain disease Patients will undergo MRI scanning of the brain and carotid and US scanning of the carotid at baseline and thereafter at 1 and 2 years or sooner if presenting clinically in order to monitor the natural history of carotid atherosclerosis and its effect on end-organ brain disease
Patients will consent to baseline scanning and follow up at 1 and 2 years and databasing of clinical and imaging data After each imaging session images will be processed stored locally and also sent to a central repository 500 patients will be recruited over a 2 year period in anticipation of study completion within 4 years
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