Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01353612
Status:
COMPLETED
Last Update Posted:
2020-02-24
First Post:
2011-05-12
Brief Title:
Correlation Between Coronary and Carotid Atherosclerotic Disease CAD and Links With Clinical Outcomes
Sponsor:
Canadian Atherosclerosis Imaging Network
Organization:
Canadian Atherosclerosis Imaging Network
Study Overview
Official Title:
Correlation Between Coronary and Carotid Atherosclerotic Disease CAD and Links With Clinical Outcomes
Status:
COMPLETED
Status Verified Date:
2020-02
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:
This is a prospective multi-center imaging study expecting to enroll approximately 1350 patients scheduled for clinically-indicated coronary angiography Following informed consent patient will undergo baseline coronary intravascular ultrasound IVUS imaging and non-invasive ultrasound imaging of their carotid arteries Following a 2-year follow-up period patients will undergo repeat coronary IVUS and standard invasive coronary angiography as well as carotid ultrasound examination
Additionally patients will be contacted by phone on an annual basis for 5 years to collect cardiovascular and cerebrovascular clinical endpoints Evaluations of plaque burden will be made using invasive and non invasive imaging tools in order to assess correlations between vascular beds imaging technologies and main cardiovascular events
Additionally patients will be contacted by phone on an annual basis for 5 years to collect cardiovascular and cerebrovascular clinical endpoints Evaluations of plaque burden will be made using invasive and non invasive imaging tools in order to assess correlations between vascular beds imaging technologies and main cardiovascular events
Detailed Description:
CTA and PET Substudy
A subset of patients enrolled into the main CAIN3 study will undergo a CTA At sites where both CTA and PET imaging modalities exist patients will be asked to undergo both tests The CTA and PET scans can be done separately on 2 imaging beds on different days or performed on the same imaging bed resulting in a combined CTA and PET scan being done in one scheduled visit All imaging will be done within 90 days after the follow up IVUS
The choice of radiotracer used NaF or FDG for PET imaging will be dependent upon site and availability on the day of the scan A total of 120 patients will be enrolled in this substudy with approximately 50-60 undergoing CTA and PET
A subset of patients enrolled into the main CAIN3 study will undergo a CTA At sites where both CTA and PET imaging modalities exist patients will be asked to undergo both tests The CTA and PET scans can be done separately on 2 imaging beds on different days or performed on the same imaging bed resulting in a combined CTA and PET scan being done in one scheduled visit All imaging will be done within 90 days after the follow up IVUS
The choice of radiotracer used NaF or FDG for PET imaging will be dependent upon site and availability on the day of the scan A total of 120 patients will be enrolled in this substudy with approximately 50-60 undergoing CTA and PET
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