Acute Coronary Syndrome, Atheroma, Atherosclerosis, Cardiac Disease, Myocardial Infarction, Vascular Diseases
Conditions
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 Queen's (CINQ, www.CINQLab.com). 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, negative/positive predictive values) of carotid plaque by CEUS (Definity(R)) 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.
Interventions
OTHERUltrasound
Contrast-enhanced ultrasound (CEUS)
Sponsors
Lantheus Medical Imaging
Dr. Amer Johri
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>18 years of age 2. Outpatients referred for clinically indicated angiography for assessment of CAD 3. Low - Intermediate Framingham risk (\<20%) 4. Absence of clinical contraindication to angiography 5. Able and willing to give informed consent
Exclusion criteria
1. Patients presenting with acute coronary syndrome 2. Patients with previously known significant CAD (any lesion \>50%) or percutaneous coronary intervention or coronary artery bypass surgery 3. Previous carotid surgery or angioplasty 4. Documented allergy to echo contrast
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plaque Height (physiological parameter) | 4 years | Caliper measurement of carotid plaque height on ultrasound images, using GE EchoPAC software. The maximum height of either side will be used to correlate to severity of angiographic CAD and neovascularization score. |
| Total Plaque Area (physiological parameter) | 4 years | Area measurement of carotid plaque on ultrasound images (right + left side), using GE EchoPAC software. The total plaque area will be used to correlate to severity of angiographic CAD and neovascularization score. |
| Neovascularization (contrast enhancement intensity) (physiological parameter) | 4 years | A neovascularization score will be used to grade the activity of the carotid plaque per participants and be correlated to angiographic CAD, visualized and manually counted using GE EchoPAC software. |
| Contrast wash-in time (physiological parameter) | 4 years | Time of contrast entering the plaque will be assessed to see if it correlates to severity of angiographic CAD, using GE EchoPAC software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants CV outcome follow-up (data linkage through the Institute for Clinical Evaluative Sciences: ICES) | 5 years | Participants will be followed for major adverse cardiac event over 5 years. Number of events will be correlated to carotid plaque measurements. |
Countries
Canada
Outcome results
None listed