Official Title: Vascular Imaging as a Barometer for the Early Detection of Cardiovascular Disease
Status: COMPLETED
Status Verified Date: 2022-06
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: VIBE
Brief Summary: The investigators plan to evaluate the correlation between carotid plaque enhancement on Contrast-enhanced ultrasound CEUS significant coronary artery disease CAD and cardiovascular CV outcomes in a systematic manner The investigators hypothesize that increased levels of CEUS-detected vulnerable carotid plaque will be predictive of CV risk determined by angiography and future cardiovascular events
Detailed Description: Study Design The investigators will conduct a prospective single-center observational study at the Cardiovascular Imaging Network at Queens CINQ wwwCINQLabcom This facility allows a CEUS protocol to be conducted on the same day as the angiogram It is anticipated that 100 participants can be recruited per month with a total target enrolment of up to 1000 participants
Objectives
1 To determine the test characteristics sensitivity specificity negativepositive predictive values of carotid plaque by CEUS DefinityR for predicting significant CAD 50 stenosis in participants referred for angiography 2 To determine the test characteristics sensitivity specificity predictive values of carotid plaque by CEUS for predicting future CV events such as death stroke myocardial infarction and cardiovascular interventions
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
Secondary IDs
Secondary ID
Type
Domain
Link
CG17006
OTHER_GRANT
None
None
ER15-11-029
OTHER_GRANT
Ministry of Research Innovation and Science - Ontario