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Collection of coronary images with a hybrid IVUS OCT system.
A prospective observational imaging study in patients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for PCI following a presentation with either stable angina or an acute coronary syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group | Other | Patients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for PCI following a presentation with either stable angina or an acute coronary syndrome. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation group | Device | Collect coronary images with a hybrid IVUS OCT system. |
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| Measure | Description | Time Frame |
|---|---|---|
| Collection of the first human coronary images with the hybrid IVUS OCT technology | The hybrid IVUS OCT system permits simultaneous and co-registered acquisition of IVUS and OCT coronary images. IVUS and/or OCT series can be recorded up to 10 cm of the vessel length or up to 20 s of imaging. The physician will review 10 frames and evaluate independently IVUS images, OCT images and the combined IVUS-OCT images for the ability to identify and characterize coronary lesion categories: lipid plaque, calcified plaque, fibrous plaque, thin fibrous cap, positive remodelling and plaque burden. Results, for each frame and imaging modality, of lesion assessment will be tabulated as: a) non-assessable, b) assessable and present, c) assessable and absent. The Clinical Report Form captures tabulated sections for each imaging modality and specific frame selected for lesion evaluation. Results will be presented qualitatively and quantitative as categorical calculations. Image interpretation will be performed independently and blinded to clinical and angiographic information. | Clinical Report Forms (capturing image analysis) will be completed for each case no later then 72 hours after the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tej Sheth, MD | Hamilton General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |