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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02696-49 | Other Identifier | IDRCB |
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In this study, the investigator propose to determine the efficiency of a new and more sophisticated imaging prototype, the Spectral Photon Counting Computed Tomography (SPCCT), at characterizing vulnerable plaques and luminal stenosis in Carotid Atherosclerosis patients compared to DECT (Dual Energy CT) and MRI (Magnetic Resonance Imaging) which are used in current practice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spectral Photon Counting Computed Tomography (SPCCT) | Experimental | The randomized SPCCT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis |
|
| Dual Energy CT (DECT) | Active Comparator | The randomized DECT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectral Photon Counting Computed Tomography (SPCCT) | Diagnostic Test | The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients < 80 kg and 1 mL/kg for patients > 80 kg, with a maximum of 90 mL. The SPCCT scanner is a prototype spectral photon-counting computed tomography system derived from a modified clinical CT system with a field of View (FOV) of 168 mm in-plane, and a z-coverage of 2 mm. |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid Necrotic Core (LNC) in mm² identified with SPCCT | measurement of the height and thickness of surface of the plaque's components | 1 month |
| Lipid Necrotic Core (LNC) in mm² identified with DECT | measurement of the height and thickness of surface of the plaque's components | 1 month |
| Lipid Necrotic Core (LNC) in mm² identified with histology | measurement of the height and thickness of surface of the plaque's components | 1 month |
| Intra Plaque Hemorrhage (IPH) in mm² identified with SPCCT | measurement of the height and thickness of surface of the plaque's components | 1 month |
| Intra Plaque Hemorrhage (IPH) in mm² identified with DECT | measurement of the height and thickness of surface of the plaque's components | 1 month |
| Intra Plaque Hemorrhage (IPH) identified with histology | measurement of the height and thickness of surface of the plaque's components | 1 month |
| Fibrous Cap Ulceration (FCU) in mm² identified with SPCCT | measurement of the height and thickness of surface of the plaque's components | 1 month |
| Fibrous Cap Ulceration (FCU) in mm² identified with DECT |
| Measure | Description | Time Frame |
|---|---|---|
| Number of irregularities identified with SPCCT | - Irregularities as defined by < 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood. | 1 month |
| Number of irregularities identified with DECT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe DOUEK, Pr | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Pradel cardiovascular Hospital | Bron | France |
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The images will be read without knowing the CT scan used
|
| Dual Energy CT (DECT) | Diagnostic Test | The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients < 80 kg and 1 mL/kg for patients > 80 kg, with a maximum of 90 mL. DECT : IQon, Philips |
|
measurement of the height and thickness of surface of the plaque's components |
| 1 month |
| Fibrous Cap Ulceration (FCU) in mm² identified with histology | measurement of the height and thickness of surface of the plaque's components | 1 month |
- Irregularities as defined by < 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood. |
| 1 month |
| Number of irregularities identified with MRI | - Irregularities as defined by < 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood. | 1 month |
| Number of ulcerations identified with SPCCT | - Ulceration as defined by > 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood. | 1 month |
| Number of ulcerations identified with DECT | - Ulceration as defined by > 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood. | 1 month |
| Number of ulcerations identified with MRI | - Ulceration as defined by > 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood. | 1 month |
| Assessable vascular segments with lack of image artifacts | It will be assessed by estimating the image quality on scale from 1 to 4 (1 = poor, 2 = moderate, 3 = good, and 4 = excellent) | 1 month |
| radiation dose received during SPCCT | 1 month |
| radiation dose received during DECT | 1 month |
| Tolerance to SPCCT assessed by a tolerance survey | 1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004 | 1 month |
| Tolerance to DECT assessed by a tolerance survey | 1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004 | 1 month |
| Tolerance to MRI assessed by a tolerance survey | 1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004 | 1 month |
| ID | Term |
|---|---|
| D021921 | Aortic Stenosis, Supravalvular |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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