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| Name | Class |
|---|---|
| Arineta Ltd. | INDUSTRY |
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Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd.
The study will evaluate a new twin source relatively compact CT scanner with advanced technology which is optimized for cardiovascular imaging. Eligible patients with a clinical indication will undergo coronary or cardiac CT scans using the new SpotLight CT from Arineta Ltd. Image quality and usefulness of the new system will then be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with suspected cardiac disease | Patients eligible for cardiac CT will be included with a focus on symptomatic patients with low-intermediate risk for obstructive coronary artery disease. Patients will undergo Cardiac CT scanning (with the SpotLight CT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac CT scanning (with the SpotLight CT) | Other | Cardiac CT scanning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Image quality (subjective) of the new SpotLight CT scanner from Arineta Ltd. | Subjective (4 grade scale) image quality assessment of coronary arteries. unassessable studies and unassessable coronary segments will be reported. | 2 years |
| Image quality (objective) of the new SpotLight CT scanner from Arineta Ltd. | Image contrast, image noise, signal to noise ratio and contrast to noise ratio. Those numerical values will be reported to allow comparisons with values previously reported with other CT scanners. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of the new SpotLight CT scanner from Arineta Ltd. | Performance characteristics of the new CT scanner for diagnosing obstructive coronary artery disease as compared to other reference standards such as invasive coronary angiography. | 2 years |
| The effect of cardiac CT results (with SpotLight CT) on patients triage |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a clinical indication for cardiac CT
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronen Rubinshtein, MD | Contact | +972-4-8250153 | ronenrub@clalit.org.il | |
| Mali Azencot, PHD-RN | Contact | +972-4-8250844 | maliaz@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Ronen Rubinshtein, MD | Carmel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carmel Medical Center | Recruiting | Haifa | 34362 | Israel |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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The effect of cardiac CT results on patients diagnosis and therfore hospitalization or discharge decisions |
| 5 years |
| The predictive value of cardiac CT results (with SpotLight CT) for patients outcome | Predictive value of cardiac CT results for adverse outcomes (death/myocardial infarction/revascularization). | 5 years |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |