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| ID | Type | Description | Link |
|---|---|---|---|
| CG#17006 | Other Grant/Funding Number | Lantheus Medical Imaging, Inc. | |
| ER15-11-029 | Other Grant/Funding Number | Ministry of Research, Innovation and Science - Ontario |
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| Name | Class |
|---|---|
| Lantheus Medical Imaging | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac outpatients | Subjects referred for outpatient coronary angiography. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Other | Contrast-enhanced ultrasound (CEUS) |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plaque Height (physiological parameter) | 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. | 4 years |
| Total Plaque Area (physiological parameter) | 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. | 4 years |
| Neovascularization (contrast enhancement intensity) (physiological parameter) | 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. | 4 years |
| Contrast wash-in time (physiological parameter) | Time of contrast entering the plaque will be assessed to see if it correlates to severity of angiographic CAD, using GE EchoPAC software. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Participants CV outcome follow-up (data linkage through the Institute for Clinical Evaluative Sciences: ICES) | Participants will be followed for major adverse cardiac event over 5 years. Number of events will be correlated to carotid plaque measurements. | 5 years |
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Inclusion criteria:
Exclusion criteria:
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Subjects referred for outpatient coronary angiography will be screened for inclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Amer M Johri, MD | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University, Cardiovascular Imaging Network at Queen's (CINQ), Kingston General Hospital | Kingston | Ontario | K7L 3N6 | Canada |
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| Label | URL |
|---|---|
| Cardiovascular Imaging Network at Queen's | View source |
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| ID | Term |
|---|---|
| D058226 | Plaque, Atherosclerotic |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D050197 | Atherosclerosis |
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| D001157 | Arterial Occlusive Diseases |
| D017202 | Myocardial Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D055585 |
| Physical Phenomena |